45
Abstracts of the Society of Quality Assurance 24th Annual Meeting Presentation Abstracts A-1 CVM Update on Review-Related Issues Herman M Schoenemann US Food and Drug Administration, Center for Veterinary Medicine, Rockville, Maryland, United States Presenter will explain the impact recent and future issues are having, or will have, on CVM’s current review processes supporting the ap- proval of new animal drugs and efforts to improve those processes. These issues include proposed changes to the user fee program, significant CVM and FDA IT initiatives, and internal CVM review improvement processes. Keyword(s): Animal Health Level: Basic (Suitable for professionals with less than two years experience). B-1 The Enigma of Regulatory Compliance in the University Sandy Hancock Virginia Tech, Virginia-Maryland Regional College of Veterinary Medicine, Blacksburg, Virginia, United States University-affiliated memberships in SQA have grown four-fold in the past ten years, implying that university participation in regulatory-compli- ant research is on the rise. Concomitant with the rise of a university presence in SQA is an increased participation of members in the University Speci- alty Section (USS). To assess the current status of regulatory work (GLP, GCP) in academic institu- tions, the USS sponsored a web-based survey of SQA members with university addresses. Ques- tions were phrased to obtain objective and subjective data about the types of studies con- ducted at universities, the organization of quality assurance functions, training programs and uni- versity-industry contract processes. The results are being used to define SQA university membership and assist the USS in developing program goals. In addition, the results of the survey have set the groundwork for the construction of a broader SQA survey to characterize the partnerships between industry and academia. Thirty percent of the targeted members re- sponded to the survey. Fifty percent of the respondents identified their roles as QA, while the remainder were study directors, PIs, con- tributing scientists, archivists and lab directors. As expected in an environment committed to competitive grant funded basic research inter- spersed with regulated contract research, QA personnel often have additional non-QA respon- sibilities. Interestingly, the diversity of regulatory research activity at universities is comparable to that found in industry with university labora- tories conducting studies requiring compliance with FDA GLPs (77%), EPA GLPs (26%), OECD GLPs (15%), human GCPs (44%) and veterinary GCPs (13%). Some universities have successfully developed university-wide regulatory programs and conduct research compliant with multiple federal regulations. The program size is reflected in the organization and functional processes of the academic QAU. Placement of regulated studies at universities can be hindered by contract negotiations with industrial sponsors. These negotiations can be lengthy, involving university sponsored programs, lawyers and individual investigators. Some universities have instituted practices to streamline the process. This presentation will discuss the results of the survey and describe the evolving university environment that has capabilities to conduct both basic research and research compliant with GLP and GCP regulations. A university laboratory Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

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Page 1: Abstracts of the Society of Quality Assurance 24th Annual Meeting

Abstracts of the Society of QualityAssurance 24th Annual Meeting

Presentation Abstracts

A-1

CVM Update on Review-Related Issues

Herman M Schoenemann

US Food and Drug Administration, Center

for Veterinary Medicine, Rockville, Maryland,

United States

Presenter will explain the impact recent and

future issues are having, or will have, on CVM’s

current review processes supporting the ap-

proval of new animal drugs and efforts to

improve those processes. These issues include

proposed changes to the user fee program,

significant CVM and FDA IT initiatives, and

internal CVM review improvement processes.

Keyword(s): Animal Health

Level: Basic (Suitable for professionals with less

than two years experience).

B-1

The Enigma of Regulatory Compliance in the

University

Sandy Hancock

Virginia Tech, Virginia-Maryland Regional College

of Veterinary Medicine, Blacksburg, Virginia,

United States

University-affiliated memberships in SQA have

grown four-fold in the past ten years, implying

that university participation in regulatory-compli-

ant research is on the rise. Concomitant with the

rise of a university presence in SQA is an increased

participation of members in the University Speci-

alty Section (USS). To assess the current status of

regulatory work (GLP, GCP) in academic institu-

tions, the USS sponsored a web-based survey of

SQA members with university addresses. Ques-

tions were phrased to obtain objective and

subjective data about the types of studies con-

ducted at universities, the organization of quality

assurance functions, training programs and uni-

versity-industry contract processes. The results are

being used to define SQA university membership

and assist the USS in developing program goals. In

addition, the results of the survey have set the

groundwork for the construction of a broader

SQA survey to characterize the partnerships

between industry and academia.

Thirty percent of the targeted members re-

sponded to the survey. Fifty percent of the

respondents identified their roles as QA, while

the remainder were study directors, PIs, con-

tributing scientists, archivists and lab directors.

As expected in an environment committed to

competitive grant funded basic research inter-

spersed with regulated contract research, QA

personnel often have additional non-QA respon-

sibilities. Interestingly, the diversity of regulatory

research activity at universities is comparable to

that found in industry with university labora-

tories conducting studies requiring compliance

with FDA GLPs (77%), EPA GLPs (26%),

OECD GLPs (15%), human GCPs (44%) and

veterinary GCPs (13%). Some universities have

successfully developed university-wide regulatory

programs and conduct research compliant with

multiple federal regulations. The program size is

reflected in the organization and functional

processes of the academic QAU. Placement of

regulated studies at universities can be hindered

by contract negotiations with industrial sponsors.

These negotiations can be lengthy, involving

university sponsored programs, lawyers and

individual investigators. Some universities have

instituted practices to streamline the process.

This presentation will discuss the results of the

survey and describe the evolving university

environment that has capabilities to conduct both

basic research and research compliant with GLP

and GCP regulations. A university laboratory

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 2: Abstracts of the Society of Quality Assurance 24th Annual Meeting

exploring the possibility of regulatory research

activities will find encouragement in discovering

the successes at other academic institutions.

Keyword(s): University/Academic Research,

Good Laboratory Practice (GLP)

Level: Basic (Suitable for professionals with less

than two years experience).

B-2

The Development of Overarching Quality Policies

and Procedures for Universities and Research

Organizations

David Brodish

RTI International, Research Triangle Park,

North Carolina, United States

Universities and research organizations face a

number of challenges. One of the more impor-

tant challenges is the maintenance of quality

assurance in the context of academic freedom to

engage in a wide range of research activities.

These research activities have limits, however,

and the development of overarching quality

policies and procedures and standards that are

integrated with mission, vision, and values can

benefit the entire organization. Furthermore,

universities and research organizations must

comply with Federal Acquisition Regulation

(FAR), as cited at 48 CFR Part 46. The FAR

may specify quality system requirements for

certain complex tasks. In addition, the Data

Quality Act (DQA) requires federal agencies to

ensure the quality, objectivity, utility, and integ-

rity of information that they disseminate. Much

of this information is developed through con-

tracts with universities and research organiza-

tions, so it is important that they have a shared

understanding of this Act. This presentation

describes key provisions of the DQA and how

RTI International (Research Triangle Institute),

one of the world’s leading non-profit research

institutes founded in 1958, has used both FAR

and DQA as a basis for developing a corporate

quality policy that serves as a foundation for

quality management systems that include GLP,

GCP, ISO 9001, ANSI/ASQC E4 and others. The

presentation will provide specific examples on

the application of quality assurance at RTI in

research, development, and technical services

dedicated to improving the human condition by

turning knowledge into practice. These research,

development, and technical services are practiced

internationally in five major fields: health,

education and training, democratic governance,

environment and natural resources, and energy

and advanced technology.

Keyword(s): University/Academic Research,

Quality Policy

Level: Basic (Suitable for professionals with less

than two years experience).

C-1

Risk Management: Assessment and Mitigation of

Risks from Licensing, Vendor, and Information

Technology Perspectives

James Bardunias*, Albert Calcagni, Roxanne

Rhault, Neil McCullough

Pfizer, WRAQA, New London, Connecticut,

United States

This 90 minute session will include a high level

review of Pfizer Worldwide Regulatory Affairs and

Quality Assurance’s Risk Based Quality Assurance

(RBQA) process. Topics of discussion will include:

* Rationale for RBQA* Goals for RBQA* Execution of RBQA

Among the discussion will include a review of

processes for risk assessment and mitigation

used by Pfizer’s Licensing, Vendors, and Infor-

mation Technology Quality Assurance (LiVIT

QA) for carrying out RBQA in the licensing,

vendor and IT QA facets of clinical trials

operations. Processes will include:

* Assigning Risk Factors* Risk Profiling

S2 Presentation Abstracts

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Page 3: Abstracts of the Society of Quality Assurance 24th Annual Meeting

* Assessing Risk Levels* Mitigating Factors* Residual Risk Usage

In each of the three areas a case study will be

presented. Each case study will include:

* Assumptions* Results* Lessons Learned

Attendees will gain a high level understanding of

LiVIT QA’s risk management paradigm and see

real life examples and results of their use.

Keyword(s): Computer Validation, Quality

Assurance, Risk Management

Level: Intermediate (Suitable for professionals

with more than two years experience).

D-1

‘Wish I’d Said That’: Promoting Quality Systems

by Writing Excellent Audit Reports

Lynn Podraza

QA Consultant, Chicago, Illinois, United States

The audit report provides a vehicle for commu-

nicating audit results. Quality Assurance (QA)

professionals recognize the audit as an impor-

tant element of a quality management system

(QMS). Independent evaluation of the QMS

provides information about performance within

the system. The audit report provides a written

record of identified nonconformities, opportu-

nities for improvement, objective evidence, and

conclusions. Do you find yourself thinking ‘I

dread writing reports; I just don’t know where

to start; writing takes me so long’?

This presentation is for audit report writers

who want their reports to be clearer, more

logical, and easier to read and understand. Well-

written reports present opportunities for im-

proving organizational effectiveness and regula-

tory compliance, educating research personnel,

and promoting the professional standing of QA

representatives.

Participants will learn techniques for improv-

ing their process for planning, writing and

revising audit reports; and learn to adjust writing

styles for the audience and methods for avoiding

common mistakes. Audit report examples will be

reviewed and critiqued.

Keyword(s): Clinical Research (GCP), Education/

Training

Level: Basic (Suitable for professionals with less

than two years experience).

D-2

‘You Can’t Always Get What You Want’ – Some

Critical Comments on Systems Audits

Rita Hattemer-Apostel

Verdandi AG, Zurich, Switzerland

Auditing is a well-established method in quality

management in the regulated industry and has

been so for many years. Subject to audit are

preclinical and clinical studies, facilities, exter-

nal providers, computerized systems, manufac-

turing and the like.

Systems audits look beyond study-specific or

project-specific documentation and procedures

with the intention to evaluate the robustness of

larger systems, their transparency and process

continuity across departmental and functional

boundaries. The goal is to identify weaknesses in

the systems that may not be detectable during

study-specific audits. Thus, the value of such

audits and their contribution to error prevention

is undeniable.

However, these audits may also come to

surprising results for those who order such an

audit. Often enough, the observations and

results – and finally the auditor’s interpretation

– of systems audits are not matching the client’s

expectations.

As research and development is performed by

humans in an imperfect environment where results

are unpredictable, errors and non-compliance

with Standard Operating Procedures (SOPs) and

Presentation Abstracts S3

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Page 4: Abstracts of the Society of Quality Assurance 24th Annual Meeting

regulations are likely to be identified in any

systems audit. The areas in which these observa-

tions are made and – equally important – the

auditor’s conclusion with regard to the overall

system subject to audit may come as a complete

surprise for the client.

Some case studies are presented on systems

audits and surprising results are discussed, as

well as the position and reaction of the client.

Audit results were outside of the client’s vision

of what such a systems audit may entail and

caused some irritation at the client.

Ultimately, however, the audit results identi-

fied the true problems and did not stop at

assessing the quality of regulatory compliance.

‘And if you try sometime you find

You get what you need.’

[Rolling Stones]

Keyword(s): Clinical Research (GCP), Audit/

Inspection

Level: Intermediate (Suitable for professionals

with more than two years experience).

E-1

Computer Validation Activities – Understanding

a QA Auditors Role in the Validation Process

Theresa A. Donegan M.S.

Charles River Laboratories, Shrewsbury,

Massachusetts, United States

As QA auditors we are responsible for auditing

many types of activities: from ongoing study

phases to data and final reports. Often, the most

intimidating activities that need to be audited

are those generated as part of the Computer

Validation process. This process includes not

only the initial validation and its documenta-

tion, but also the operation and maintenance

activities whose documentation is required to be

maintained in support of the system during its

use in a regulated environment. For auditors

who do not consider themselves ‘technical’ and

have little knowledge of the system being

validated, participation in the Computer Valida-

tion Process can be a daunting task. This

presentation will detail a QA auditor’s respon-

sibility with respect to the validation effort and

the system documentation and will provide

guidance in how to audit these activities, as

well as tips for working with the Validation

Team to maximize QA’s contribution in the

validation process.

Keyword(s): Computer Validation, Preclinical

Research (GLP), Good Laboratory Practice

(GLP)

Level: Basic (Suitable for professionals with less

than two years experience).

E-2

Process Capture by Camtasia Software for

Computerized System Validation

Michael Regehr

BASF Corporation, Research Triangle Park,

North Carolina, United States

TechSmith‘s Camtasia can be used in prepara-

tion for computerized system validation. Process

capture (video recordings of user actions) by

Camtasia has resulted in QAU and Validation

Engineer time savings.

QAU time savings come through test script

uniformity from scripting rules or harmoniza-

tion (rule enforcement) by a Validation Leader.

Validation Engineer time savings come through

process captures using Camtasia rather than

script writing. Uniformity is also increased with

a single translator converting process captures

into test scripts.

Camtasia Recorder captures full-motion video

and adds voice narration, highlighting, labels,

and timestamps. Camtasia Studio allows editing

of video files. Camtasia Player allows playback

of videos during test script writing.

The pilot study for Camtasia included two

Validation Engineers and 45 Camtasia record-

ings resulting in 13 test scripts. Example videos

S4 Presentation Abstracts

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Page 5: Abstracts of the Society of Quality Assurance 24th Annual Meeting

include process captures, error capture, and

software demonstration.

Keyword(s): Computer Validation, Software

Level: Basic (Suitable for professionals with less

than two years experience).

E-3 Withdrawn by author.

F-1

Establishing Successful Management Structures

to Support GLP Studies in Academic Institutions

Debra Bridges*1, Marilyn Marshall2, Melissa

Eitzen3, Idoia Apraiz4, Idoya Calvo4, Catherine

Bens5, Laurie Sower3

1Texas A&M University, College Station, Texas,

United States, 2University of Arizona, Tucson,

Arizona, United States, 3University of Texas

Medical Branch, Galveston, Texas, United

States, 4University of Navarra, Pamplona,

Navarra, Spain, 5USDA-NWRC, Fort Collins,

Colorado, United States

Establishment of effective GLP management in

academic institutions is often a complicated task as

there is not always a direct alignment with existing

institutional hierarchy and a knowledgeable, com-

mitted GLP management structure. This USS

sponsored session will begin with a presentation

that contains an overview of the regulation

requirements, with an emphasis on the challenges

and obstacles that academic institutions face when

establishing successful management structures.

Following the presentation, management structures

will be presented from Texas A&M University, the

University of Arizona, the University of Texas

Medical Branch, and the University of Navarra,

Spain. At the close of the presentations, the floor

will be opened for an interactive discussion on

management structures. Participants are encour-

aged to bring management structure examples and

questions in order to promote an interchange of

successes, concerns, and possible solutions.

Keyword(s): University/Academic Research,

Management

Level: Intermediate (Suitable for professionals

with more than two years experience).

G-1

Oops! What Happened? Investigating Anomalous

Results in a GLP/Bioanalytical Environment

Jacquelynn Karau

PPD, Quality Assurance, Middleton, Wisconsin,

United States

There is an increasing expectation in the

pharmaceutical industry that organizations have

a formalized procedure to investigate anomalies

that arise during the course of a GLP/Bioanaly-

tical study. Organizations in the GLP/Bioanaly-

tical arena may be struggling with how to meet

this growing expectation. This presentation will

review why this expectation is occurring, issues

that may arise when developing an investigation

procedure, when organizations should initiate

an investigation, the basic components of an

investigation as well as what kind of documen-

tation is required. This presentation is not

intended to be a forum for debating the merits

of an investigation procedure or endorse a

certain way of investigating or documenting an

investigation. An example investigation will be

reviewed in the presentation.

Keyword(s): Bioanalysis, Preclinical Research

(GLP), Investigations, Deviation Investigation

Level: Basic (Suitable for professionals with less

than two years experience).

G-2

‘GMP Creep’ into Bioanalysis: Should

Bioanalysis Fight it or Can We Learn from it?

Irina Colligon*

PAREXEL Consulting, Lowell, Massachusetts,

United States

For those deep on the inside, bioanalysis and

pharmaceutical manufacturing have nothing in

Presentation Abstracts S5

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Page 6: Abstracts of the Society of Quality Assurance 24th Annual Meeting

common. Ask an educated outsider, and you

hear a different story: it’s all about chemistry

and doing it ‘right’. So who is right? Is there

nothing in common or, to paraphrase George

Bernard Shaw, are these two subjects separated

by a common terminology?

This session will examine, from the side of

Bioanalysis, the above questions and some of the

possible answers to them. We will consider if

there is a common ground that can be used for

the benefit of both sides on their path to

improving the quality of their work? In looking

for different approaches to leveraging what

GMP has to offer, we will look at the applic-

ability and application of the key concepts of

Quality Systems Regulations (QSR) and Quality

by Design (QbD).

Keyword(s): Bioanalysis, Preclinical Research

(GLP), Good Manufacturing Practice (GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

G-3

Challenges in ‘Auditing’ when Transitioning

from the Laboratory to QA

Khonesavanh Vilayphone

Charles River Laboratories Preclinical Services,

Worcester, Massachusetts, United States

Many times one of the most frustrating and

confusing experiences for a new auditor is trying

to determine the best ‘Approach’ to auditing.

Even with a good training program in place and

specific SOPs and guidelines, this can still be

overwhelming for a first time auditor. Coming

from a GLP, bioanalysis lab setting the views

and expectations of an auditor’s role are

completely different. This presentation will

discuss some of the hurdles that may be

encountered for an auditor who has transitioned

from a scientist role to an auditing role.

Keyword(s): Bioanalysis, Preclinical Research

(GLP), Quality Assurance

Level: Basic (Suitable for professionals with less

than two years experience).

H-1

Building an Internal Audit Program in a

Small Service Company – Understanding the

Expectations for Planning, Implementing and

Maintaining an Internal Audit Program

Cheryl McCarthy

Eliassen Group, eClinical Solutions Division,

Mansfield, Massachusetts, United States

Introduction: To provide guidance on establish-

ing an internal audit program in a small service

company. Geared toward the CRO/Sponsor

institution that is implementing an internal audit

program as part of their quality system.

Methods: Evaluate the components of an

internal audit program and identify methods to

ensure:

* Proper definition for your company of the

purpose of the program* Appropriate management support – including

maintaining independence of the audit program* Understanding of the different phases –

planning, implementation and maintenance* Identification of the quality system proce-

dures that need to be put in place* Management of the associated documenta-

tion created to support an internal audit* Efficient interview techniques when discuss-

ing audit topics with personnel* Efficient documentation review of documen-

tation for the audit topic* Management of the findings and observations

found during the audit and follow-up to

ensure expected corrective actions have been

implemented

Results:

* Defined purpose for an internal audit program* Management support is provided to the audit

program, which results in benefits to the

compliance and efficiency of the company as

a whole

S6 Presentation Abstracts

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Page 7: Abstracts of the Society of Quality Assurance 24th Annual Meeting

* Applicable quality system procedures in place

to support the planning, implementation and

maintenance of an internal audit program* Audit performance is efficient* Audit documentation is managed and main-

tained – including identification of the com-

ponents of the audit report and audit response* Findings and observations are trended to

determine areas of non-compliance* Corrective actions are approved and followed

through completion

Discussion:

* Review a case study of the implementation of

an internal audit program in a small service

company (CRO)* Discuss the audit component of the Quality

System Regulations and how it impacts the

management oversight and documentation

created to support an internal audit program* Includes an audience participation activity

that highlights some of the common findings

of internal audits

Keyword(s): Clinical Research (GCP), Audit/

Inspection

Level: Basic (Suitable for professionals with less

than two years experience).

I-1

Bioanalytical Method Validations: Study

Director, Report Coordinator and Quality

Assurance Roles

Wendi Godwin*1, Dean Haan2, Robert Henry3

1MPI Research, Quality Assurance, Mattawan,

Michigan, United States, 2MPI Research,

Analytical Services, Mattawan, Michigan,

United States, 3MPI Research, Report Services,

Mattawan, Michigan, United States

Introduction: The purpose of this abstract is to

present the concept of a 90 minute training

session that will demonstrate the roles of three

key players in the development and reporting of

a bioanalytical method validation study. The

three roles that will be explored will be that of

the Study Director, Report Coordinator and

Quality Assurance.

Methods: The goal of the training will be for

the trainee to be able to follow a bioanalytical

method validation study from start to finish,

including an understanding of the roles of three

of the key players. A Study Director, Report

Coordinator and Quality Assurance Auditor

will be presenting the details of each of their

roles in completing a bioanalytical method

validation study, from protocol design to signing

the final report.

Results: The result of the training will be for

the trainee to be able to follow a bioanalytical

method validation from start to finish, including

an understanding of the roles of three of the key

players. The training will include a detailed

presentation from a Study Director’s perspective

on designing a protocol for a bioanalytical

method validation study. It continues to follow

through to demonstrate the Study Director’s role

in study conduct and reporting the study results.

Next, the Report Coordinator’s role will be

explored, which will illustrate involvement in

creating the bioanalytical method validation

report. The Quality Assurance role will also be

discussed, including their role in the review

of the protocol, in-process inspections and

auditing the final bioanalytical method valida-

tion report.

Discussion: The design, execution and report-

ing of a bioanalytical method validation study is

an integral part of a pre-clinical and clinical

study. By exploring the current requirements/

guidance documents and the roles of three of the

key contributors to the study design, attendees

will be able to better understand the process,

enabling them to be stronger contributors to

their organizations.

Keyword(s): Bioanalysis, Preclinical Research

(GLP), Method Development/Validation

Level: Basic (Suitable for professionals with less

than two years experience).

Presentation Abstracts S7

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J-1

Medical Device Regulatory Update

Janet H Cooper

FDA/Center for Devices and Radiological

Health/Office of Compliance, Rockville,

Maryland, United States

A US Food and Drug Administration represen-

tative will provide an update on agency policies,

expectations and inspection activities.

Keyword(s): Clinical Research (GCP), Medical

Devices

Level: Basic (Suitable for professionals with less

than two years experience).

K-1

Advancing Your Career through Strategic Job

Searching

Scott Szczensy

PharmaLogics Recruiting, Braintree, Maryland,

United States

As the Bio-Pharmaceutical industry continues to

change and evolve, it becomes increasingly more

challenging to identify the job opportunities that

make sense for you personally. There always seem

to be plenty of QA jobs available but how do you

determine the right time to make a change?

There are many variables that come into play

when evaluating a potential new position: Timing;

Location; Company Size; Job Title; Growth

Potential; Compensation etc. How do you decide

if the opportunity is the right step for you? How

do you become aware of the opportunities that do

exist? Why do certain colleagues achieve advanced

positions quicker than others? Learn how to make

sure your career stays on the path you envision.

Get tips on gaining additional responsibility in

your current position and ensuring yourself of

upward mobility in the future.

Keyword(s): Personal Development/Training,

Education/Training

Level: Basic (Suitable for professionals with less

than two years experience).

K-2

Mentoring the QA Professional

Karen Evans

GlaxoSmithKline, King of Prussia, Pennsylvania,

United States

The current business climate demands efficiency

and quality practices that are integrated into all

activities. This makes it imperative for the QA

professional to continue to grow within their

field. One way this can be accomplished is

through a Mentor/Mentee relationship. These

relationships tend to be either with the new

employee or with a colleague who possesses the

skills and knowledge that one could learn from.

Both relationships are structured and defined.

The new employee mentor relationship is

typically driven by the Mentor. The Mentor

should be a QA Professional who is well versed

in the company objectives, goals, and policies as

well as an experienced Auditor. First, the Mentor

will assess the basic needs of the new employee

and develop a plan and a timeline. Typically, the

plan would include trainings needs. Types of

training to consider are company and depart-

mental procedures, basic auditing techniques

(QC vs. QA), technical training, and appropriate

business etiquette. As the relationship progresses,

it will be the responsibility of the Mentor to

carry out the plan and adjust the plan to fit the

needs of the new employee until Management

feels that the new employee is ready to fulfil all

the duties required to carry out the position.

In contrast to the new employee, a mentor

relationship with a colleague should be driven

by the Mentee. The Mentee should identify what

expectations and goals they have for the

Mentor/Mentee relationship. Next, they should

determine what background, education, and

skill set the Mentor would need to posses to

help them accomplish the goals they are after. It

is then important for the Mentee to outline the

roles and responsibilities of the relationship and

S8 Presentation Abstracts

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set clear objectives with their Mentor. Finally,

the Mentee needs to review the plan periodically

to make sure expectations have not changed.

There are several ways all employees can benefit

from the Mentor/Mentee relationship. While the

benefits to the Mentee appear to be obvious,

Mentors also benefit through the ongoing chal-

lenge to their professional expertise and to think

outside the box. The Mentor/Mentee relationship

will enhance the careers of both parties through

learning and professional development.

Keyword(s): Personal Development/Training,

Education/Training

Level: Basic (Suitable for professionals with less

than two years experience).

L-1

Quality Risk Management in GCP and

Pharmacovigilance: The Future of Quality

Assurance

Kenneth Schiff*, Rupesh Patel

Hoffmann LaRoche, Inc., Nutley, New Jersey,

United States

Is the long-established approach of sampling in

Quality Assurance still valid?

When we look at the size of scope a Quality

Assurance group in a global, multinational

pharmaceutical company has to deal with, we

find about 20,000 individual entities from

headquarter functions to affiliates to service

providers to clinical trial centers.

Can we truly build confidence in the data and

ensure patients’ safety by drawing conclusions from

a limited number of audits, data reviewed and

clinical trial centers assessed? Do we really learn

from past experience or do we come across the

same findings over and over again in our audits?

Does sampling do justice to the diverse world of

GCP and Pharmacovigilance where we observe a

great variance in the way trials are planned,

managed and monitored, in medical practice at the

national and global level and also on how quality

control and quality assurance is performed?

This session will follow up on last year’s session

and focusses on how a comprehensive Quality

Risk Management approach works and why it is

superior to the current sampling approach. It will

outline the benefits, on one hand to pharmaceu-

tical companies and on the other to health

authorities, investigators and ultimately the pa-

tients using selected examples and case studies.

The advantages of a Quality Risk Management

approach are becoming increasingly obvious as

industry and regulators are faced with new

challenges: trial complexity is still increasing as

new technologies are introduced in addition to

budget restrictions and limited resources.

This calls for a transparent and proactive

approach for prioritizing compliance activities

and for the early detection of potential system

failures.

Presentations will focus on:

* Reiterate Quality Risk Management princi-

ples and the advantages they bring compared

to a traditional auditing approach,* Quality Risk Assessment of spontaneous

safety reporting and clinical trial centers with

specific examples and case studies,* How to use the results of a Quality Risk

Assessment to initiate systemic process im-

provements.

Keyword(s): Clinical Research (GCP), Risk

Management

Level: Intermediate (Suitable for professionals

with more than two years experience).

M-1 - FDA-CVM Reviewer Insights

Harlan J Howard, Angela K Clarke

US Food and Drug Administration, Center

for Veterinary Medicine, Rockville, Maryland,

United States

Each reviewer will present material regarding

best practices of submitted clinical and non-

clinical studies, what reviewers look for in the

Presentation Abstracts S9

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studies, and how reviewers interact with com-

panies before and during the review process.

Keyword(s): Animal Health

Level: Basic (Suitable for professionals with less

than two years experience).

N-1

From Human Research Volunteer to Bioanalysis

– Quality Perspectives on Human Bio-Sample

Processing and Shipment

Chad Westhoven*1, Eric Humes2

1Avantix Laboratories, Quality Assurance, New

Castle, Delaware, United States, 2ICON

Development Solutions, Ellicott City, Maryland,

United States

The Bioanalytical Specialty Section (BASS) and

Clinical Specialty Section (CSS) of the Society of

Quality Assurance (SQA) developed an overview

process map after holding two (2) roundtable

discussions regarding the best practices in obtaining

biological samples from human subjects at a clinical

site and, shipment and receipt of the biological

specimens to the bioanalytical laboratory.

The discussion groups mainly consisted of

Quality Assurance (QA) Professionals whose audit-

ing focus was either clinical (GCP) or bioanalytical

(GLP). The goal of CSS and BASS was to present

SQA members with a unique perspective on one of

the most critical processes ensuring data integrity of

Pharmacokinetic (PK) and/or Pharmacodynamic

(PD) clinical studies – biological sample control

between the clinic (e.g. investigator site, CRO) and

the bioanalytical laboratory.

The 60 minute joint session will cover issues

associated with getting human bioanalytical

samples from clinic to the lab. This would

include a presentation of the process map, an

overview of why the two groups felt the process

map was necessary, the issues at hand, the

process used to generate the information and

some of the strengths and weaknesses of the

resulting process map. The session presenters are

volunteer CSS and BASS members who were

involved in the roundtable discussions.

Keyword(s): Bioanalysis, Clinical Research

(GCP), Good X Practice (GXP, Multidisciplinary)

Level: Basic (Suitable for professionals with less

than two years experience).

O-1

Aspect and Challenges of Audit Classification

Procedures

Beth Moulaison

Charles River Laboratories Preclinical Services –

MA, Shrewsbury, Massachusetts, United States

How can we communicate the quality of the

work we are auditing? Is the quality measured

by the number of findings in a Quality Assur-

ance audit? Is it determined by the impact the

finding has on the study? How can we make

management aware of quality concerns? What

message are we sending if metrics are not well

developed? It is clear that management looks to

Quality Assurance for a score card on their

performance. This presentation will review

examples of audit classification procedures and

the need to have meaningful metrics to summar-

ize the information collected to allow manage-

ment to make decisions regarding improvement.

Keyword(s): Preclinical Research (GLP), Quality

Metrics

Level: Basic (Suitable for professionals with less

than two years experience).

O-2

Key Issues to Consider in Conducting GLP

Compliant Research for the Pharmaceutical

Industry in China – Perspectives from a Contract

Research Organization in China

Paul Sidney

Charles River Laboratories PCS-Montreal,

Quality Assurance, Senneville, Quebec, Canada

S10 Presentation Abstracts

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Contract Research Organizations (CRO) in pre-

clinical research in China is a relatively new and

developing service. This form of support to the

drug development process is an expected progres-

sion of the rapid growth of the Pharmaceutical &

Biotechnology industry in China. Many pharma-

ceutical firms are initiating & conducting pre-

clinical research in China to allow them to submit

to the Chinese sFDA and International Health

Authorities. This presentation will focus on key

issues to consider when assisting a Chinese CRO

in their processes & procedures to meet current

international government & industry expected

laboratory standards. The Chinese sFDA GLP

regulations have been promulgated in China

recently and GLP research is at the early stages

of implementation. Chinese CROs have the

challenge of meeting the standards established

by US & European laboratories that have been

conducting GLP regulated studies for more than

25 years. The latter quality standards established

by North American & European CROs can be

met in China through well planned training &

recruiting programs, transfer of experienced key

staff for extended periods and collaboration with

an experienced International preclinical labora-

tory. The presentation will discuss some of the

key elements and process of sharing expertise

with the Chinese CRO’s to ensure Government

and sponsor expectations are met. The first step

would be to conduct a gap analysis between the

Chinese sFDA GLP regulations (enacted Septem-

ber 2003) and International GLP regulations,

which will be tabled in this lecture. Subsequent to

the analysis of the regulatory differences a GLP

program would be implemented to address the

following elements – personnel training & facility

management & communication (technical, pro-

fessional & sponsor/CRO communication meth-

odology), transfer technical expertise, quality

systems (QC & QA) to ensure international

regulatory compliance, current concepts of ani-

mal care & welfare (e.g. AAALAC standards),

physical infrastructure (vivarium design & vali-

dation, equipment) and documentation standards

(protocol, SOPs, report, data & computer sys-

tems). This presentation will provide the key

differences of the Chinese sFDA GLP regulations

and current international GLP regulations and

practical considerations in implementing current

expectation of applying international GLP reg-

ulations in China.

Keyword(s): Preclinical Research (GLP), Chinese

State FDA GLP Regulations, GLP Research

Conducted in China

Level: Intermediate (Suitable for professionals

with more than two years experience).

O-3

Ten Attributes for an Effective Quality Assurance

Unit

John Yergler

JDY Consulting and Training, Fishers, Indiana,

United States

This presentation provides a brief summary and

discussion of personal observations taken from

nearly twenty years of working with Quality

Assurance Unit (QAU) personnel and the QAU

customers. The observations are categorized

into ten attributes or qualities.

A gulf may exist between the QAU and the

customer that can limit the effectiveness and

potential of the QAU. Facility management’s

attitude toward the QAU and the QAU’s

behavior can have a great impact on how the

unit is perceived by the customer.

This presentation first addresses facility man-

agement’s quality responsibilities and the impact

that management can have on the relationship

between the facility and the QAU.

Also discussed is the customer’s perception of

the QAU. Is the unit perceived as the policeman

who hides behind the hedge and merely issues

the ticket? Or is it viewed as the helpful person

who assists folks along the way?

While acknowledging that management’s at-

titude toward quality and compliance often sets

the tone, many times the QAU-customer rela-

tionship may result from the way that QA,

either individually or collectively, has interacted

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with the facility personnel or issued the reports.

While good and poor examples are presented,

frustrations that may exist on both sides of the

quality and compliance fence are also discussed.

The underlying goal of the presentation is to

suggest that QAU’s conduct a self-examination

and assessment by comparing themselves/their

operation to the ten attributes. As examples, the

first attribute, ‘be knowledgeable,’ challenges

the QA professional to know the function of the

Quality Assurance Unit. The second attribute,

‘be accessible,’ encourages QAU personnel to be

available for consultation and discussion. This

will assist in overcoming the customers’ percep-

tion of QA as the police.

The ten attributes, if possessed first by the

individual members of the QAU, should move a

QAU from the group that indifferently points

out errors and deviations to one that serves a

well-respected and valued function.

Keyword(s): Preclinical Research (GLP), Quality

Assurance

Level: Basic (Suitable for professionals with less

than two years experience).

P-1

Serious and Continuing Non-compliance: How

IRBs and Sponsors Can Work Together to

Manage Non-Compliant Sites and Protect

Human Subjects

Theresa Straut*1, Deborah Waltz2

1Chesapeake Research Review, Inc., Columbia,

Maryland, United States, 2King Pharmaceuticals,

Cary, North Carolina, United States

The FDA IND regulations require Sponsors to

monitor the progress of investigations. If a

Sponsor discovers that an investigator is not

complying with the investigator’s general re-

sponsibilities (as delineated in FDA form 1572),

the Sponsor is required to promptly secure

compliance or cease investigational drug ship-

ment and end the investigator’s participation in

the investigation. If the Sponsor must terminate

the investigator’s participation, the Sponsor is

required to inform the FDA.

The IRB, per FDA regulations, has the

authority to suspend or terminate approval of

research that is not being conducted in accor-

dance with the IRB’s requirements or that has

been associated with unexpected serious harm to

subjects. If the IRB suspends or terminates

approval, the IRB is required to inform the FDA.

The Sponsor and the IRB have an overlapping

concern in that both wish to ensure compliance

with study, regulatory, and IRB requirements.

However, traditionally, contact between the IRB

and Sponsor has been limited. Both must be able

to act independently of each other, but this does

not preclude information sharing, especially as it

may impact subject safety.

Situations of serious or continued on-compli-

ance are not only a risk to a Sponsor’s data, they

also place human subjects at increased risk.

With an effective communication between the

Sponsor and the IRB, the IRB is able to evaluate

potential risks from a higher vantage point and

proactively manage the situation.

Using a collaborative framework, the two

speakers will outline two cases of serious and

continuing non-compliance, which occurred on

two separate trials sponsored by the company of

the first speaker, and overseen by the second

speaker’s company, an independent IRB.

The speakers will provide the audience with

tips and techniques for breaking down barriers

to communication that may exist within their

own organization as well as methods for

effective interactions with the IRBs. Practical

strategies for the prospective development of

procedures to handle these situations will be

shared as well as examples of what works and

what doesn’t work.

At the conclusion of this presentation, parti-

cipants should be able to: (1) Define serious and

continuing non-compliance, (2) Dispel false

notions and provide new insights into the value

of the Sponsor/IRB interface, and (3) Under-

stand how the Sponsor/IRB interface can be an

effective tool in ensuring data quality and

human subject protections.

S12 Presentation Abstracts

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Presenters will initiate the session with a slide

presentation, which will provide the regulatory

framework around investigator non-compliance.

Then the presenters will provide two case studies

dealing with challenging clinical research issues.

Presenters will consist of senior representatives

from an AAHRPP Accredited Central IRB and

from Pharmaceutical Industry Quality Assur-

ance. Time will be reserved for an interactive

Q&A between the presenters and the audience.

Keyword(s): Clinical Research (GCP), Risk

Management

Level: Intermediate (Suitable for professionals

with more than two years experience).

Q-1

EPA-GLP Regulatory Update

Francisca Liem

US Environmental Protection Agency, Washington,

District of Columbia, United States

Ms. Liem will provide an update on agency

policies, expectations and inspection activities.

Keyword(s): Good Laboratory Practice (GLP)

Level: Basic (Suitable for professionals with less

than two years experience).

R-1 Withdrawn by author.

R-2

Report from Industry: Digital Signature Standards

and Shared Digital Identities Creating Significant

Productivity Gains and Cost Reductions in the

Pharmaceutical Industry

Rich Furr

SAFE-BioPharma Association, Ft Lee, New

Jersey, United States

Successful implementations of digital signature

standards and shared digital identities in a

spectrum of applications (including eSubmis-

sions, eLab Notebooks, ePrescribing, and Elec-

tronic Data Capture) by leading pharmaceutical

companies is demonstrating the practical value

of streamlining electronic information exchange

and identity assurance. These early adaptors are

enjoying significant productivity gains and time

and cost reductions from decreased paper

management, improved operational efficiency,

and increased productivity, and are helping

define the digital identity and digital signature

standards currently migrating to the entire

healthcare sector.

This presentation will review – from both a

regulatory and legal perspective – the current

state of digital signatures and electronic submis-

sions in the healthcare industry, including

advantages, costs, and limitations of the existing

model. Additionally, the presentation will report

on several real-world examples of how pharma-

ceutical companies are streamlining operations

through the growing use of digital signatures.

These examples include AstraZeneca’s use of the

SAFE digital signature standard to sign its FDA

submissions and Procter & Gamble’s use of the

SAFE digital signature standard in its Electronic

Laboratory Notebook (ELN) project, reaching

4500 people inside the company. Other exam-

ples include an eSampling pilot program in

which physicians order samples using the SAFE

digital identity and signature, thereby permitting

a significant reduction in the time between

placement of orders and receipts of samples.

The SAFE digital signature standard provides

a secure, enforceable, and regulatory compliant

way to verify the identities of parties involved in

business-to-business and business-to-regulator

electronic transactions. The standard was devel-

oped by SAFE-BioPharma Association for use

within the pharmaceutical and healthcare in-

dustries. Use of the SAFE standard facilitates

interoperability and integration among research-

ers, vendors, regulators, clinicians, and other

pharmaceutical and healthcare stakeholders.

SAFE BioPharma is a consortium of leading

pharmaceutical companies founded by AstraZe-

neca, Bristol-Myers Squibb, GlaxoSmithKline,

Johnson & Johnson, Merck, Pfizer, Proctor &

Gamble, and Sanofi-Aventis.

Presentation Abstracts S13

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Keyword(s): Computer Validation, Electronic

Signature

Level: Intermediate (Suitable for professionals

with more than two years experience).

S-1

Licensing Due Diligence and Quality Assurance

Roxanne Rhault

Pfizer, Worldwide Regulatory Affairs and Quality

Assurance, QA, New London, Connecticut,

United States

Pharmaceutical and Biotechnical companies are

constantly engaged in activities to either in-

license, out-license, co-develop or co-market

new compounds. Quality assurance plays a

significant role in these activities. Non-compli-

ance with regulations not only poses a risk to

regulatory approval but could significantly im-

pact the business cost associated with bringing a

new drug to market.

This 90 minute session will holistically orient

the Quality Assurance Professional to the due

diligence activities undertaken by an organiza-

tion and specifically examine the contributions

by GLP, GMP, GCP, and Pharmacovigilance

(PV) Quality Assurance.

The opening presentation will orient QA profes-

sionals to due diligence activities and include:

* Why companies engage in due diligence* The due diligence lifecycle from opportunity

identification to business agreement execution* How due diligence opportunities are surfaced* Building the due diligence team* Value of the due diligence report* QA involvement in the business agreement

Each GxP and PV presentation will address:

* Inclusion on the due diligence team* An in-depth review of what each QA

discipline focuses on* Pre-due diligence activities* On-site due diligence activities* Due diligence reporting activities/examples* Beneficial auditor skill set(s)

Keyword(s): Preclinical Research (GLP), Clinical

Research (GCP), Manufacturing (GMP), Licensing

due Diligence

Level: Intermediate (Suitable for professionals

with more than two years experience).

T-1

Clinical Regulatory Update

US Food and Drug Administration and Health

Canada Representatives Invited

US Food and Drug Administration and Health

Canada representatives have been invited to

provide an update on agency policies, expecta-

tions and inspection activities.

Keyword(s): Good Clinical Practice (GCP)

Level: Basic (Suitable for professionals with less

than two years experience).

U-1

FDA-GLP Regulatory Update

US Food and Drug Administration Representative

Invited

A US Food and Drug Administration repre-

sentative has been invited to provide an update

on agency policies, expectations and inspection

activities.

Keyword(s): Good Laboratory Practice (GLP)

Level: Basic (Suitable for professionals with less

than two years experience).

V-1

GMP Symposia: GMP Specifications: Establishing,

Controlling and Meeting Requirements - Ensuring

Suppliers & Sub-Contractors Meet Specifications:

An Overview

Gretchen McAuliffe

eM2 Solutions, Inc., Pearland, Texas, United

States

S14 Presentation Abstracts

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In today’s global marketplace, selecting and

qualifying suppliers and sub-contractors has

become a vital component in the development

and manufacture of drugs and medical devices.

Two main factors are driving this initiative.

First, more companies are purchasing raw

materials & components from overseas manu-

facturers. In addition, an enlarging number of

companies are outsourcing key elements of the

R&D and production processes. These two

factors are driving the FDA to increase scrutiny

of the procurement process. The agency holds

the firm responsible for ensuring that any

materials, outsourced processes, or services

comply with regulatory standards.

It is important that manufacturers and

laboratory/research facilities adequately define

the specifications for goods and services re-

ceived, and communicate these requirements to

their vendor. However, this is only the initial

component to a robust qualification program. A

diligent company must also assess risks, and

perform follow-up activities, such as audits and

data review. In addition, implementing preferred

supplier programs may provide economic ad-

vantages for both the sponsor and supplier.

This presentation will discuss the regulatory

requirements for control of materials and

services. In addition, it will provide an overview

of a supplier qualification program and current

industry trends in the qualification process. The

speaker will also examine important program

considerations for different types of suppliers.

Presentation Outline

I. Regulatory Requirements for Control of

Materials

II. Qualified vs. Certified

III. Essentials of Supplier Qualification Program

* Establish Specifications* Global Management Strategy (risk assess-

ment)* Quality Agreement* Supplier Dossier* Assessment Audits (on-site and paper)* Certificate of Analysis* Change Control Notification

IV. Preferred Suppliers

V. Important Considerations for Different

Supplier Types

* Raw Materials* Packaging Components* Subcontract Laboratories* Subcontract Manufacturers* Warehousing & Distribution

Keyword(s): Manufacturing (GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

V-2

GMP Symposia: GMP Specifications: Establishing,

Controlling and Meeting Requirements - First-

time Scale-up: How to Establish a Specification

when You’ve Never Made more than Gram

Quantities

James Ault

Ricerca Biosciences, LLC, Concord, Ohio,

United States

Developmental processes by their very nature are

research at best. The scale up from a laboratory

hood to a Kilo Laboratory or Pilot Plant is not

typically a straight-forward project. There are

issues of explosive solvents or reagents, reaction

end-pointing and sheer mass differences that must

be accommodated. This presentation will discuss

how these ‘problems’ are accommodated and

how early developmental-stage specifications are

established for unknown purity and yield calcula-

tions that are required before processing may be

started. Comparability of batches is always a

predominant issue, and efficient development

versus optimization of process many times is at

odds for meeting the requirements for new drug

entities.

Keyword(s): Manufacturing (GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

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V-3

GMP Symposia: GMP Specifications: Establishing,

Controlling and Meeting Requirements - The

Quality Unit Function for Releasing an API for

Clinical Supplies

Angela Peischl

Ricerca Biosciences, LLC, Concord, Ohio,

United States

When an API is released for use in Clinical

Studies, the quality unit’s role in approval not

only ensures the chemistry is correct, but that

the integrity of the material is sound. In order to

manufacture API’s for Clinical Supplies, the

Quality Unit must be involved in all quality-

related documents. This entails being part of

policy and facility procedures, as well as project

mobilization.

* This presentation will cover the core proce-

dures required of an API for Clinical Trials to

be manufactured according to the ICH

Guidance, specifically, the responsibilities

given to a Quality Unit.* Outline:* Responsibilities of the Quality Unit (ICH

Q7A, section 2.2)* Policies for Project Mobilization and Facilities* Test Methods* Transfer, Develop/Validate Test Method* Raw Materials and Components* Procurement* Receipt* Inspection/Quarantine/Sampling* Testing* Release and Labeling* Equipment* Cleaning* Set up/Line Clearance* Processing* Finishing/Packaging of Product* Batch Records* Master Batch Records* Batch Record Issuance* Review* Disposition Issuance* Final Product

* Labeling* Quarantine/Sampling* Release Testing* Inspection, Labeling and Storage* Distribution of Final Product

Keyword(s): Manufacturing (GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

W-1

Building and Maintaining a Successful Risk

Management Alliance

Carol Bognar

PAREXEL, Charlottesville, Virginia, United

States

Initiating a long term strategic alliance between a

Consultancy and Pharma is a significant under-

taking and maintaining the partnership is con-

firmation that mutually beneficial outcomes are

the end result. To date, over 400 Global GCP

Investigator site audits have been conducted in

over 30 countries during this engagement. The

key to this successful endeavour has been a

combination of a proactive method of risk

management by the client and employing a

seasoned and consistent audit team that has

remarkably remained stable since the inception

of the project. The ability of the team to be

flexible and accommodate the unique audit and

reporting requirements of the client that have

continued to evolve each year has been the

cornerstone of the program. In order to control

costs and secure a reduced fee, a travel share

approach was instituted, which diminished both

the travel time and expenses up to 50% by

geographically grouping site locations into one

trip or combining them with other clients. With

each new annual agreement, the challenge

remains to implement the use of innovative

sponsor specific tools and become efficient with

new methods of reporting audit results. The latest

change has decreased the report writing time 25-

50% for a mutual benefit and also maximizes the

S16 Presentation Abstracts

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quality risk management approach. As sponsors

continue to recognize the benefits of pro-active

auditing and mitigating risk via the audit func-

tion, it is expected that engagements such as this

one, will continue to lead to long term, mutually

beneficial relationships.

Keyword(s): Clinical Research (GCP), Audit/

Inspection

Level: Intermediate (Suitable for professionals

with more than two years experience).

W-2

Building an Effective Clinical QA Unit with

Internal and External Resources

Jennifer O’Brien*, Sonja Curran

Falcon Consulting Group, GCP Services, Chapel

Hill, North Carolina, United States

QA and QC activities are an integral part of

any clinical program and require a staff of

adequate number and expertise to be effective.

For a small company, the clinical quality

assurance unit is likely to be understaffed or

possibly even nonexistent. Large pharmaceutical

companies have QA units that cycle through

growth and downsizing periods. Depending on

where they are in this cycle, the QA unit might

be out of synch with the demands of current

clinical activities. For both of these situations,

QA activities can be completely outsourced.

This scenario, while convenient, is not the most

cost effective means of addressing QA needs

over the long-term. A more effective and

efficient model of a clinical QA unit is the

integration of both internal and external re-

sources. The internal component is essential for

ensuring adequate management of the clinical

QA program, establishing goals that meet

corporate objectives, and facilitating ongoing

communication with senior management. The

external component is determined by the short-

term needs of the company at any given time so

the number and expertise of these resources can

vary as needed.

Keyword(s): Clinical Research (GCP), Clinical

QA Unit

Level: Intermediate (Suitable for professionals

with more than two years experience).

W-3

Building Bridges While Maintaining Objectivity

– Learning to do the Quality Two Step

Tabitha Westbrook

Copernicus Group IRB, Quality Assurance,

Research Triangle Park, North Carolina, United

States

Problems and areas of noncompliance exist

within every organization. The goal of any

internal auditing system is to identify those

areas. Most companies recognize the need for a

robust internal auditing system; however, suc-

cessfully implementing one can be extremely

difficult. The most critical aspect of achieving

such a system is to be able to walk the fine line

between being a consultant, or team player, and

maintaining the independence and objectivity

required for auditing. Walking that fine line

enables you to build bridges between QA and

operational groups while still being able to

maintain objectivity and look at ‘the big

picture.’ Mastering this concept enhances the

quality of the organization and helps to prevent

future noncompliance by encouraging commu-

nication between operational groups and QA.

Sometimes QA professionals misinterpret the

requirement for independence and objectivity. In

a GCP environment the QA auditor often plays

many roles. A GCP auditor can go directly from

conducting and internal systems audit to hosting

a third-party audit of their own organization.

Additionally, GCP auditors are relied upon to

interpret regulations and guidances and to

provide advice regarding compliance.

This 30-minute session will stress the impor-

tance of recognizing which role is being played

and the importance of each role. This session

will also discuss the appropriate way to provide

Presentation Abstracts S17

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consultancy while remaining objective. The

presentation will be in MS PowerPoint format

and will include real-life, common sense situa-

tions in which auditors have been asked to ‘two

step’ between auditor and consultant. Example

situations will be provided and the audience will

be asked to weigh in regarding whether the

auditor has acted appropriately.

This session will help the QA professional to

* Understand the importance of building rela-

tionships with operational departments* Identify the skills necessary to build the

relationships* Differentiate between being an independent

and objective auditor and a QA consultant

and recognize when each role is appropriate

Keyword(s): Clinical Research (GCP), Internal

Systems Audits

Level: Basic (Suitable for professionals with less

than two years experience).

X-1

Bioanalytical Regulatory Update

US Food and Drug Administration Representative

Invited

A US Food and Drug Administration repre-

sentative has been invited to provide an update

on agency policies, expectations and inspection

activities.

Keyword(s): Bioanalysis

Level: Basic (Suitable for professionals with less

than two years experience).

Y-1

UAMS BioVentures – a GMP Facility in a

University Environment

Raymond Anderson

University of Arkansas for Medical Sciences,

Research Support Center, Quality Assurance

Unit, Little Rock, Arkansas, United States

BioVentures offers a University of Arkansas for

Medical Sciences client company access to many

University resources including a 16,500 square

foot new business incubator facility. This facility

contains a GMP laboratory facility capable of

supporting IND Phase 1 and early Phase 2

manufacturing. Client company support in this

facility includes an office, wet lab, access to the

GMP laboratory space and many UAMS re-

sources and support services.

Frequently client companies evolve from the

results of clinical research conducted at the

university and during their early development

require continued Quality Assurance support

through the university on a cooperative basis.

Support is provided for protocol development,

preparation of CMC sections for IND submis-

sions, SOP writing, equipment qualification,

personnel training and other items unique to

working in a GMP environment.

This presentation will present and discuss

some of the Quality Assurance challenges faced

in the qualification, start up and operation of the

facility in the university community.

Keyword(s): University/Academic Research,

Good Manufacturing Practice (GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

Y-2

University R&D Biomedical Management and

the Effects on Quality

Idoya Calvo*, Idoia Apraiz

University of Navarra, Pamplona, Spain

The University has always been the cradle of

new ideas and R&D projects. The University is

the propelling force of applied R&D in order to

respond to the necessities of the society.

In the past few years, the relationship between

the university and industry is more and more

significant. Therefore, the University has needed

to adapt in order to respond not only to

S18 Presentation Abstracts

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industry, but also to society, legislation and so

on.

In 2002, the Spanish government published a

Spanish family of standards (UNE 16600X:

2002EX) which set up requirements for a

general R&D Management System. These re-

quirements attempt to make the R&D process

more effective.

However, these standards are applicable to all

R&D sectors, and it is known that the biome-

dical and pharmaceutical R&D process becomes

more difficult and complex with time. Normally,

the product of this R&D process is innovative

medicine, and because of its activity and

purpose, it is subject to a more demanding

regulatory framework than any other product.

This session will show:

* The results of a comparative analysis of the

classic Quality Management Systems (GLP,

GMP, GCP, ISO 9001) versus UNE

166002:2002EX to determine the extent of

R&D management that the classic systems

have. To make this comparative, the require-

ments have been grouped into five elements:

Management system, Management responsibil-

ities, Resources management, R&D activities

and Measurement, Analysis and improvement.* Focusing on the Management responsibilities,

the following points will be analyzed:* Identification of the Management in the

organizational structure of the University* Leadership, responsibility, authority and

communication through University* Decision-making models using tools such

as knowledge management, competitive

intelligence and the balanced scorecard* The consequences of these facts on Quality,

considering:* Normative compliance* QAU authority* Assignment of human and facilities

resources to R&D activities, in particu-

lar, GLP studies.

Keyword(s): University/Academic Research,

Good X Practice (GXP, Multidisciplinary),

management

Level: Intermediate (Suitable for professionals

with more than two years experience).

Z-1

Medical Device - Multipurpose Audits Combining

ISO 13485 Based Audit and FDA Establishment

Inspection

Marc-Henri Winter

G-MED North America, Silver Spring, Maryland,

United States

How can medical device manufacturers reduce

their regulatory burden and save time?

The harmonization of the national regulations

is certainly the most awaited regulatory progress

in the Medical Device industry since different

countries and regions of the world already share

convergent views on many regulatory issues. For

instance the specific requirements applicable to

the quality management system are now pretty

similar worldwide.

Accompanying this trend, third party organi-

zations (also called auditing organizations (AO),

registrars, notified bodies, conformity assess-

ment bodies. . .), were either allowed or required

by most regulatory agencies, to assess the

compliance of the quality management systems.

As a consequence, the AOs have been taking

into account for many years the specificities of

national and international regulations to per-

form audits, the core of their services they

render to medical devices manufacturers.

Even though one can claim today that a single

organization can handle all together the statu-

tory evaluations required for the commercializa-

tion of a medical device in different regions of

the world, there are still two major poles in term

of audit/inspection practices:

* the USA specific regulation (QSR) and in-

spection practice based on the Quality System

Inspection Technique (QSIT) and the Com-

pliance Program 7382.845* the group of countries that refer to ISO 13485

and whose auditing practices are essentially

Presentation Abstracts S19

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based on ISO 19011 and guidelines from the

International Accreditation Forum (IAF).

In this regulatory environment, is it still techni-

cally and practically possible to combine all the

references and practices in one assessment

process that can satisfy all the national health

competent authorities?

The presentation gives an update about the

guidance documents on how to perform an audit

combining both the US inspection requirement

and the ISO and IAF guidelines.

It also details the current and promising Pilot

Multipurpose Audit Program between the FDA

and Heath-Canada.

Keyword(s): Manufacturing (GMP), Medical

Devices, Audit, Inspection, Harmonization,

FDA, Health-Canada, GHTF, Audit/Inspection

Level: Intermediate (Suitable for professionals

with more than two years experience).

Z-2

Key Considerations and Factors for Successful

Development of Drug Eluting Beads

Hind Goreish

Knowledge Excellence UK Ltd., London, United

Kingdom

Purpose

Drugs loading into embolic beads for local drug

delivery can be very challenging when loading

hydrophobic crystal forming drugs; here we

present these challenges, how to overcome them

and key factors to consider for the successful

development of a drug eluting beads.

Materials and Methods

Ibuprofen eluting beads (IEB)

Biocompatibles UK Ltd. Bead Block is loaded

with ibuprofen (crystal forming and hydropho-

bic drug) using propriety method. Challenges of

loading of the drug were; poor drug uptake,

quick elution, poor product appearance, crystal

formations on the beads surface melts upon

sterilization leading to beads aggregation thus

affecting the suspension and deliverability of the

beads. To overcome the loading challenges, two

drying steps were introduced into the loading

process. Aggregation, suspension and deliver-

ability issues were examined after incorporation

of a crystallization inhibitor (CI) into the

loading process after screening a range of

polymer and oil based excipients.

In vitro Characterization of the Ibuprofen

eluting beads

The product elution at two different doses was

examined (85mg/mL and 25 mg/mL beads),

elution was evaluated using T-apparatus and a

rapid elution test. Eluted drug concentration at

specified time points was determined by HPLC.

Beads shape and sizes were evaluated using

image analysis. Other product characteristics

examined were compressibility, ethanol/dye re-

sidues, suspension and deliverability.

Results

The new loading methods lead to enhanced

loading and the ability to control ibuprofen

concentrations to be loaded into the beads. Slow

elution of drug using T-apparatus (t1/2 =58hrs).

Beads with higher concentrations eluted in 300

minutes vs. 100 mins. for beads with the low

drug dose. Image analysis showed good recovery

of beads shape and size to that prior to drying

and loading. The compressibility, ethanol/dye

residues, suspension and deliverability were

comparable with the unloaded commercially

available Beads Block.

Conclusions

For a successful drug eluting bead product

development and loading crystal forming hydro-

phobic drugs into hydrogel beads a combination

of key factors must be considered at an early

stage of the product development. These include

the drug choice (which and why), drug supplier,

excipients selection, regulatory considerations,

good manufacturing processes, project manage-

ment, staff training and competency.

Keyword(s): Medical Devices, Drug Deliver

Product Development

S20 Presentation Abstracts

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Level: Intermediate (Suitable for professionals

with more than two years experience).

AA-1

Auditing for Human Subject Protection

Lysa Triantafillou

Copernicus Group IRB, RTP, North Carolina,

United States

Often, auditors are confused about the term

‘human subject protection’ and what it means in

the context of the work that they perform. This

session will re-introduce auditors to the regula-

tory requirements governing human subject

protection, the historical and current application

of the Belmont Report, and an overview of the

specific responsibilities of the investigator, of the

IRB, and of the monitor in protecting human

subjects in clinical research.

We’ll discuss FDA and OHRP regulations and

guidance documents, as well as the ICH E6

Guidelines for GCP, as they relate to human

subject protection. Special emphasis will be given

to the new FDA (draft) and OHRP guidance

documents on the reporting of adverse events and

unanticipated problems involving risks to subjects

or others, as these documents address what

information should be sent to IRBs.

We’ll discuss the similarities and the subtle

differences between the FDA and OHRP regula-

tions, as well as the importance of the Common

Rule. The session will include discussions of

vulnerable populations and special protections

that may be needed.

We’ll clarify the different roles played by the

investigator, the monitor, the sponsor/CRO, and

the IRB and examine how these are intended to

work together to assure the protection of

research participants. We’ll look at the various

components of human subject protection, in-

cluding but not limited to:

* subject recruitment and advertising* informed consent (process and documentation)* (subject) privacy and confidentiality (of records)* conflict of interest

* subject reimbursement and payment for

participation* assessing the risk vs. benefit profile* IRB initial review and approval* continuing review* unanticipated problems involving risks to

subjects or others* compliance with the protocol and reporting

deviations* changes in study status* compliance with the regulations

Surprisingly, many auditors report that they

have not read the Belmont Report or that they

read it many years ago but have forgotten the

content and importance of the document. We’ll

discuss the Report and the three underlying

principles of respect for persons, beneficence,

and justice as well as the auditor’s role in

verifying that they’ve been upheld.

Often there is uncertainty about what infor-

mation should be provided by the investigator to

the IRB. This sometimes leads to under report-

ing of critical information that might impact the

IRB’s ability to approve or to continue approval

of a research study or to over-reporting of non-

essential information that may bog down the

IRB. We’ll discuss how clinical auditors can have

a better understanding of the requirements of

specific IRBs and how they can verify that all

required reports have been made.

Keyword(s): Clinical Research (GCP), Human

Subject Protection

Level: Intermediate (Suitable for professionals

with more than two years experience).

BB-1

Assuring Electronic Data Integrity in an

Evolving Clinical Trial Environment

Harry Huss

Charles River Laboratories, Horsham,

Pennsylvania, United States

Clinical trials have become more complex in

scope and design, while computerized system

Presentation Abstracts S21

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technologies used to support these trials are

evolving in architecture, platform, and size.

Additionally, the regulations governing the use of

computerized systems in clinical trials and related

guidance documents must be incorporated into

our trial design and computer system require-

ments. Part 11 considerations, the expanded scope

of trial consideration, and the rapidly changing

technologies used in clinical trials have raised

concern regarding the need for new strategies to

control electronic data integrity. This presentation

will attempt to demonstrate that these ‘new’

strategies must first be based upon traditional

concepts of control such as the ‘ALCOA’ test for

record integrity and good validation practices for

computerized systems. Specific problems areas of

clinical trial electronic data integrity will be

identified and points-to-consider related to these

problem areas will be discussed.

Keyword(s): Computer Validation, 21 CFR part

11

Level: Advanced (In-depth review of topic).

BB-2

Clinical Investigators and Part 11? Are You

Crazy?

Lisa Olson

i3 Research, Cary, North Carolina, United

States

Use of electronic systems in clinical trials

continues to grow, especially at clinical sites.

These can range from electronic data capture

(EDC) to electronic patient diaries, electronic

receipt of lab data, to digital images and even

electronic medical records. Although FDA reg-

ulatory expectations for site and sponsor respon-

sibilities have not changed, we can find ourselves

not applying them appropriately to the ‘e’ world.

Guidances often wake us up and get us to pay

attention. This talk will look at the FDA

Guidance on ‘Computerized Systems Used in

Clinical Investigations,’ issued in May 2007, and

its impact and expectations for clinical trial sites.

Keyword(s): Computer Validation, 21 CFR

part 11

Level: Advanced (In-depth review of topic).

BB-3

The Next Part 11 Opportunity for the QA

Professional

Richard Siconolfi*

Procter & Gamble Co., Mason, Ohio, United

States

The Quality Assurance Professional’s next op-

portunity is advising their employers and clinical

sites how best to comply with FDA’s guidance on

Computer Systems Used in Clinical Investiga-

tions. It really comes down to approach. What’s

in the guidance? What are your work processes?

What’s different between them? The key here is

‘really’ understanding how your clinical investi-

gations function from protocol to report. Once

you break the guidance and your work processes

you’ll see it comes down to data handling and

integrity with a dash of quality to spice it up.

Keyword(s): Computer Validation, 21 CFR

part 11

Level: Advanced (In-depth review of topic).

CC-1

Hot Topics in Biotechnology

Chantal March, RQAP-GLP

AQUA Bounty Canada, Inc., St John’s,

Newfoundland, Canada

Each year, new products enter the marketplace

as a result of biotechnology. These products are

developed and registered by following regula-

tions typically specified by multiple government

agencies (e.g. USDA, EPA, FDA). As the science

of biotechnology evolves, the regulations asso-

ciated with products are also evolving. Under-

standing the current requirements and

expectations and partnering with industry

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groups and the regulators in the development of

future regulations and guidance are important

pieces in the regulatory process.

This session will provide:

* An overview of the benefits and uses of

animal biotechnology including applicable

US and Canadian regulations/guidance* A discussion of recent industry and govern-

ment initiatives in Agricultural Biotechnology

Quality Management

Keyword(s): Biotechnology, Animal Health,

New Drug Application (NDA)

Level: Basic (Suitable for professionals with less

than two years experience).

DD-1

Risk Management in the GMP World

Howard Cooper*1, Dennis Runser2, Peter

Ackerman3

1EQACT Inc, Indianapolis, Indiana, United

States, 2TMI Regulatory Compliance

Consulting, Overland, Kansas, United States,3Advanced Medicals Consortium LLC,

McCordsville, Tennessee, United States

Risk-management is a frequently discussed topic

during discussions. Its impact is pervasive

throughout the product life cycle-from design

to post approval and marketing.

The purpose this symposium is to increase the

understanding of risk management by providing

informative and experienced perspectives that

will provoke discussion and the sharing of your

questions and experiences concerning this all-

important topic.

In our regulatory world, we discuss the topic

of risk quite frequently and how we apply our

understanding about it can mean the difference

between success and failure of our product, our

operations and even our company. Risk applies

throughout the product lifecycle and our per-

spective and understanding is greatly influenced

by our role in the lifecycle. Each of us sees risk

from the framework and perspective of our

product and regulatory environment. This in-

volvement may be research, design, scale-up,

testing, maintaining the operation, and learning

from users of the product. The nature of the

product – device, drug, or combination product

– impacts this perspective and our need for

additional knowledge.

This symposium focuses on the principles

of risk and their practical application. It does

this by:

General Introduction

Opening general summary of the status of risk

issues in the FDA regulated industries.

Speaker 1-Explain Q9-Scope-Gen Process-

Other highlights

Speaker 2- Explain ISO 14971-Scope-Gen

Process-Other highlights

Speaker 3 Explain GHTF SG3-Scope-Gen

Process-Other highlights

Discussion of commonalities between the

standards

Discussion of difference between the stan-

dards

FDA 483 Citations

Question & Answer

Keyword(s): Good Manufacturing Practice

(GMP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

EE-1

From Avian Flu to Bee Hives to Subject

Substitutions – the Uncovering of Fraud

Cheryl Bissey-Black

UCB, Inc., Smyrna, Georgia, United States

The discovery of fraud can be a multi-step

process. In the case of a clinical site in Lithuania,

this is exactly what happened. The purpose of

this presentation is to describe the steps leading

to the suspicion of fraud, the discoveries that

followed and how this may have been avoided.

Presentation Abstracts S23

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The referenced Lithuanian site had been

visited by the State Medicines Control Agency

of Lithuania on two separate occasions and

identified misconduct. The Principal Investigator

was relieved of his duties and disqualified from

conducting clinical trials in Lithuania. It was

during training of the new Principal Investigator

that the monitor determined that the former PI

intentionally did not provide the subjects’

medical records.

Once the review of subjects’ medical records

began, several unreported serious adverse events

were discovered. In cooperation with the CRO,

a ‘for cause’ audit was conducted. Approxi-

mately nine unreported serious adverse events

were discovered. Two of the serious adverse

events were unreported deaths. One of the study

nurses revealed that some subjects who had

either died or withdrawn from the study were

substituted with other subjects assuming their

identity. Nine of ten subjects from a double-

blind pivotal trial did not meet inclusion criteria.

Study medication records raised suspicion and it

was determined that while records indicated

some subjects received study medication, it had

been discarded.

The monitors for the studies had identified in

monitoring reports that subject medical records

were not provided. However, management did

not act on the reports. An audit of another site in

Lithuania identified a similar problem with

medical records yet action was not taken to

ensure that all sites in all countries provide

access to original medical records.

A review and comparison of adverse events

for all sites in all countries revealed a low

incidence of adverse events at this site.

Improved oversight of ongoing trials can

identify outliers requiring additional attention.

It is the challenge of the QA professional to

ensure that all those involved in the conduct of

clinical trials understand GCPs and that the

safety of the subject far outweighs enrolment of

subjects or the meeting of deadlines.

Keyword(s): Clinical Research (GCP), Good

Clinical Practice (GCP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

EE-2

Compliance Problems Identified in Ethical

Review: An Analysis of US FDA Warning Letters

and Reflection on Audit Experiences in Europe

Rita Hattemer-Apostel

Verdandi AG, Zurich, Switzerland

Ethical review of clinical trials is a cornerstone

in clinical and development and should ensure

the protection of the rights, safety and wellbeing

of human subjects involved in a clinical trial and

provide public assurance of that protection

through review and approval of trial protocols,

the suitability of investigators, facilities and

informed consent procedures and documents.

In the US, the system of oversight in drug

development includes inspections at Institu-

tional Review Boards (IRBs), which are con-

ducted by the Food and Drug Administration

(FDA). Approximately 15% of FDA Good

Clinical Practice (GCP) inspections are per-

formed at IRBs, resulting in approximately 100

IRB inspections/year. Only few inspections lead

to regulatory action, e.g. a Warning Letter.

Outside the US, Ethics Committees (ECs)

operate in accordance with the regulatory frame-

work of the respective countries in which they are

located. In Europe, for example, ECs are not

subject to Regulatory Authority inspections to

assess the ECs’ compliance with laws, guidance

documents and the operating procedures. How-

ever, as responsibilities and tasks of ECs and IRBs

are fairly identical, deficiencies observed at IRBs

may also be prevalent in ECs. At present, it is

only the FDA who publishes information on

regulatory compliance of IRBs or ECs.

The results of a quantitative and qualitative

analysis of the deficiencies identified in IRB

Warning Letters from 2004 to 2007 are pre-

sented. Following review and categorization of

inspection findings to cluster the information,

areas of non-compliance are highlighted and

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their relevance in relation to clinical research

compliance is discussed.

These results from the US are compared with

audit observations related to EC review made in

European audits. Overall, the deficiencies are

largely comparable between the US IRBs and the

European ECs.

Conclusions are drawn and suggestions for

improvements of the ethical review system are

made. Introducing Quality Management (QM)

Systems in IRBs/ECs would be an investment; how-

ever, without the regulatory need for a QM system

– and with no enforcement of EC compliance in

Europe – this remains a voluntary activity.

Keyword(s): Clinical Research (GCP), Quality

Metrics

Level: Intermediate (Suitable for professionals

with more than two years experience).

FF-1

Protocol Essentials – Avoiding Pitfalls and Tips

for a Successful Study

Deborah Garvin, RQAP-GLP

Pacific Rim Consulting, Inc., Mt. Hood, Oregon,

United States

A poorly written protocol results in an equally

poorly conducted study. Although basic proto-

col details are outlined in the GLPs, additional

requirements are found in guidance documents.

There are certain ‘dos’, ‘don’ts’ and industry

standards that have evolved over time. This

presentation will look at protocol requirements,

helpful hints, and avoidable pitfalls when devel-

oping protocols for GLP studies, using Target

Animal safety studies (which are generally

multi-site studies) as a base.

Keyword(s): Animal Health, Preclinical

Research (GLP), Multisite Studies, Protocols

Level: Intermediate (Suitable for professionals

with more than two years experience).

GG-1

Beyond the Data: Ensuring and Maintaining

Quality beyond the Study Data

Ian Vanterpool*, Barbara Litzenberger, Nicki

Iacono

Huntingdon Life Sciences, East Millstone, New

Jersey, United States

Client and regulatory inspections have evolved

into a far more encompassing effort than simple

evaluation of a data package against the study

report. As the regulatory environment expands

its reach into areas previously untouched, we are

challenged to ensure that our quality systems

reflect the focus of our customers and ensure

ongoing improvement is part of daily life. Given

today’s outsourcing needs, there is more empha-

sis than ever placed on ensuring that systems are

sufficiently robust to support a growing, chan-

ging workforce within a CRO.

We aim to highlight the inherent challenges in

keeping pace with the expectations of our

compliance programs in today’s world, and

recommend some solutions to maintain and

grow the quality profile via illustrations and

examples from the training, equipment and

compliance perspectives presented by both

scientific and quality assurance professionals.

Keyword(s): Preclinical Research (GLP), Personal

Development/Training, Audit/Inspection

Level: Intermediate (Suitable for professionals

with more than two years experience).

HH-1

Risk Management in the GMP World

continued from DD-1

II-1

GCP Auditing in Foreign Countries

Pamela Aiello

PAREXEL Consulting, Lowell, Massachusetts,

United States

Presentation Abstracts S25

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Auditing in other countries bring challenges to

the US monitor and auditor that one may not be

prepared for. Having to overcome cultural,

communication and language barriers adds an

extra degree of difficulty in performing the audit

or monitoring visit.

Preparation and planning ahead of time are

important aspects of making a visit to a foreign

country pleasurable, a learning experience, and

can help overcome any challenges you may

encounter. In this presentation, I will explore

nuances in select regions of the world such as

Italy, South America and Ireland, and give

helpful information as preparation to include

regulations, customs, communication styles and

cultural differences.

Keyword(s): Clinical Research (GCP), Auditing,

Audit/Inspection

Level: Intermediate (Suitable for professionals

with more than two years experience).

II-2

CSI*: South America (*Comprehensive Survival

Instructions)

Don A. VanDevender

PAREXEL Consulting/PAREXEL International,

Lowell, Massachusetts, United States

The presenter has performed more than 30 GCP

audits in Latin, South and Central America. He

will provide information that will allow for a

successful trip planning and auditing experience.

He will share his experiences from his travels so

that those traveling ‘south of the border’ may

better anticipate and prepare for the challenges

of traveling to and auditing in South America.

Keyword(s): Clinical Research (GCP), Audit/

Inspection

Level: Basic (Suitable for professionals with less

than two years experience).

S26 Presentation Abstracts

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Poster Abstracts

PP-1

Metric-based Quality Improvement System

Jill Nabors, Jessica Dutton*

ABC Laboratories, Inc., GLP Quality Assurance,

Columbia, Missouri, United States

This abstract outlines a new internal program

established by the GLP operations and GLP

Quality Assurance groups at Analytical Bio-

Chemistry (ABC) Laboratories. The purpose of

the program is to quantify the quality of GLP

reports produced by our scientists and to

provide a mechanism for management reporting

and oversight.

The metrics-based program was developed

around eight, well-defined dimensions of qual-

ity: ‘compliance,’ ‘protocol deviation,’ ‘SOP

deviation,’ ‘documentation deficiency,’ ‘method

deviation,’ ‘table error,’ ‘report error’ and

‘other.’ After a Quality Assurance auditor re-

views a GLP report, the Study Director or

Principal Investigator (SD/PI) is given the

opportunity to respond to the findings. Com-

ments that required a change in the data or

preparation of a deviation were scored and

tallied according to the category of each finding.

Results are reported by study type, Study

Director, type of finding, and number of QA

comments per binder – providing actionable

information about individual and organizational

performance. Metrics are compiled into a single

management report that shows trend over time.

In conjunction with capturing these metrics,

an ABC operations director implemented a new,

standardized business process that includes

more diligent data review by operations before

reports are submitted to QA. This includes an

in-lab QC process in which data are checked by

a second party the day they are generated. In

addition, study directors review data within 72

hours of completion of the analytical run to

monitor scientific integrity, and adherence to

SOPs, protocols and methods. The director also

established individual performance goals based

upon program metrics to provide benchmarks

for her team’s professional development.

Implemented in November 2006, ABC

Laboratories’ new GLP QA reporting program

has dramatically improved quality and time-

liness of reports. Prior to implementation, QA

identified an average of 65 possible quality

issues per study binder. Within just one month,

that number dropped to fewer than 30. In July

2007, the average number of comments per

binder was 15. This is a 77% improvement from

November 2006 to July 2007. The program also

has dramatically reduced the time required to

carry out audits and deliver QA-reviewed

reports.

Although not specifically required by regula-

tory guidelines, management controls such as

standardized workflow processes, performance

metrics and reporting to executive management

are powerful tools for ensuring compliance.

Even more importantly, these controls promote

continuous quality improvement within ABC

Laboratories’ operations, leading to better ser-

vice and enhanced client satisfaction.

Keyword(s): Quality, Quality Metrics

Level: Basic (Suitable for professionals with less

than two years experience).

PP-2

Quality Improvement and Quality Assurance: A

Partnership in Study Success

Tanja McAulay*, Louise McLean, Lise Dallaire

CIRION Biopharma Research, Laval, Quebec,

Canada

The value of a Quality Assurance program has

been a key requirement for any GLP organiza-

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Poster Abstracts S27

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tion since the GLPs were first introduced in the

1970s. The Quality Assurance role of providing

an independent review of quality and assurance

to Management allows a continuous check and

balance of quality practices. The role of Quality

Systems in an organization is a relatively new

concept and provides an added value to a GLP

organization in such that processes and proce-

dures may be improved without having the

independent constraints of Quality Assurance. It

is a proactive rather than reactive approach. It is

thus imperative that Quality Assurance and

Quality Improvement work together to commu-

nicate findings, view trends, and improve

procedures to further monitor continuous im-

provement for an effective quality program.

At CIRION, the Quality Systems department

works closely with the independent Quality

Assurance group to ensure findings are not just

answered but evaluated and further used as part

of a continuous improvement process. Whereas

Quality Assurance reports directly to Manage-

ment, the Quality Systems group is more open to

interact with all departments to identify pro-

blems, propose resolutions, and aid in the

continuous improvement of processes.

Effective tools are required to identify areas to

improve and trend potential problems. Electro-

nic QA finding reporting systems allow the

ability to trend findings based on type, severity,

and area of the enterprise. This will also allow

the QA observations to be immediately reported

to the affected person or area allowing effective

communication, finding resolution, and report-

ing to Management. A summary report is easily

produced allowing each area to see how their

department improved (or not) for each quarter

year.

Other tools such as performance metrics are

also tracked by each department thus ensuring

involvement from the source to immediately act

on downward trends before they are noted in an

audit. Other examples such as kit tracking and

ordering, electronic data management and ver-

ification tools, a global scheduling and reporting

system, and open communication between

departments will all contribute to a study

success and continued improvement of all levels.

Quality Improvement and Quality Assurance

both have an important role to play in any GLP

study and it is essential that effective commu-

nication is provided to all departments. This

must be done both from an independent quality

assurance viewpoint, but also from a quality

systems approach where the regulatory insight

provided will impact change directly in a pro-

active approach.

Keyword(s): Preclinical Research (GLP), Clinical

Research (GCP), Multisite Studies, Personal

Development/Training, Quality Metrics

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-3

Compliance Evaluation Spreadsheet

Kurt Myers

Taylor Technology, QAU, Princeton, New

Jersey, United States

Everyone loves to be evaluated! As an auditor in

a bioanalytical lab I know how at ease people

feel when I am looking over their shoulder

watching their every aliquot, I can just sense the

soothing qualities it instils. Monitoring to assure

conformance with regulations and SOPs is how

we evaluate compliance. Deficiencies found in

this compliance assessment should be linked to

guide improvements in company processes and

training. But can this compliance assessment

really help the company without a tool to make

its’ findings transparent and relevant to all

personnel! This poster presents a tool

Taylor Technology’s QAU has developed to

link our compliance evaluation to our process

improvement and training activities through-

out the Company. To perform an evaluation of

compliance you have to use data for measure-

ments and know what data sets you want

to measure. Since items related to compliance

were the focus, three sources of data were

used: The auditing database (for observation

process and type), the LIMS system (for

S28 Poster Abstracts

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analytical run information), and the SOP man-

agement database (for document review time-

lines). The compliance worksheet was created in

EXCEL and consists of two worksheets for

every month, the compliance table and the

monthly charts. There are also two summary

worksheets for the compiled year to date data. A

‘Key’ worksheet and informational display of

how the compliance table works were added

to the end of the EXCEL worksheet to describe

where data are being collected from, and

how the compliance factors are generated in

the compliance worksheet. The weighting

table can be used to input the importance

(in the form of a %) that is assigned to each of

the compliance factor calculations. The weight-

ing table is designed to alert you if the overall %

assigned to all compliance factors goes over

100%. The analysis of the % runs from the

compliance wks table can show the productivity

levels of different groups as measured by their

analytical runs. Some sort of a basic measure

of productivity is essential in this application.

During development it was found that the

groups producing the least analytical runs

had the best overall compliance %. Less work

correlated with greater compliance (or less

audit findings). To encourage productivity

over inactivity the compliance factors

were weighted and then a separate analytical

run data weighting was applied to normalize the

compliance % according to a measure of

productivity

From charts

The yearly bulls eye chart has the compliance

data graphed with the data from each compli-

ance measure represented as a spoke on the

chart. An overall view of company compliance

can be viewed here

The yearly ‘Compliance % by month’ chart

can show us useful monthly trends in overall

compliance. The yearly ‘monthly %’ chart

tracks the individual compliance measures by

month for the year and can show growing areas

of improvement or concern.

Keyword(s): Bioanalysis, Personal Development/

Training, Quality Metrics

Level: Basic (Suitable for professionals with less

than two years experience).

PP-4

Directions in Providing Productive and

Comprehensive Surveillances that will Effectively

Evaluate Compliance Issues

Barbara Jo Ann Boyd

Southwest Research Institute Chemistry and

Chemical Engineering Division, San Antonio,

Texas, United States

The proper planning, performance, and report-

ing of surveillance activities assures that com-

pliance issues are met for the quality program

required. Criteria taken into account in order to

provide a productive and comprehensive sur-

veillance are the type of scheduled surveillance,

preparation tools required and taken into

account prior to the actual surveillance, the

actual physical surveillance conducted, inter-

views performed, areas of potential concern,

reporting aspects, compliance issues and finally

the follow ups required following the conduct of

the surveillance.

The directions utilized in planning and

performance of the surveillance activities,

provide a number of tools that enable the

assessor to evaluate the quality programs for

compliance. Items of evaluation include but are

not limited to training, equipment, facilities, the

use of checklists, and a variety of documents

such as compliance documents and internal

procedures.

A good training program will provide the

proper tools that will allow an assessor with

good skills, the ability to evaluate areas of

concern that may be factors not readily seen.

These factors may show up within the surveil-

lance, during, or following the actual observa-

tion activities and require the assessor to revisit

specific issues.

Surveillance activities may be general to a

process or program element, or they may be

specific to an operation or regulation require-

ment. Examples of areas of surveillances

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performed consist of facility and equipment,

qualification and training, procedural, software

and hardware, program oriented, equipment,

records, documentation, and defined regulatory

requirements. Surveillances may involve a fol-

low up activity to a previous finding that

requires verification and closure of a deficiency

or corrective action.

Examples of types of surveillances, inspec-

tions, or audits, consist of process,

system, compliance, and product. The process

surveillance identifies the actual practice

and should involve following a procedure on

the basis of how to do the process. The system

surveillance provides a mapping of the proce-

dures to assure that the organization has a

quality system. The compliance surveillance is

typically a desktop process that identifies the

regulatory element and whether it meets the

requirements. The product surveillance provides

validation or verification of the final product,

which may be a product to specification or

documentation to methodology. When combin-

ing the type and area for a surveillance the

assessor will be able to provide answers to who,

what, when, where, and why response issues.

Surveillances may also be conducted through

scheduled or unscheduled announcements. Sur-

veillances will provide the answers to who,

where, what, when and why. Surveillances,

audits, and inspections are conducted to remove

traps and provide preventive actions. These

functions enable the quality system to tighten

the nuts and bolts of the organization and

provide ease of the regulatory audit.

Performance or process surveillances may

involve procedures and work instructions ap-

plicable to the activities being evaluated. These

activities may also consider qualifications of

personnel performing the activity, the equipment

used, and calibration status of measuring and

test equipment. This type of surveillance will

involve acceptance criteria for the surveillance

to assure that compliance with the applicable

procedure, standards, and specifications are met.

Keyword(s): Bioanalysis, Preclinical Research

(GLP), Manufacturing (GMP), Medical Devices,

Quality Assurance

Level: Basic (Suitable for professionals with less

than two years experience).

PP-5

A Review of the Sponsor Approach to Monitoring

Contract Research Organisations: A CRO

Perspective

Andy Fulford*, Kirstie Hamilton

Covance Laboratories, Harrogate, North

Yorkshire, United Kingdom

GxPs place responsibilities on companies that

sponsor regulatory work to maintain oversight

of the conduct of subcontracted activities.

However, there is little in the way of prescriptive

guidance for Sponsors in terms of precisely how

they should fulfil these responsibilities. As a

result, there are a wide variety of approaches

employed by Sponsor organisations.

Covance Laboratories Harrogate (CLEH) is

involved in the conduct of preclinical studies

under GLP, provision of QC analytical support

for GMP activities, and analytical support for

clinical studies. Conducting this work in support

of hundreds of different Sponsor companies

annually, we experience the full range of

Sponsor monitoring programmes.

A review of Sponsor audits of our facility

conducted between 2002 and 2007 reveals the

extent of variations in approach. Our analysis of

these data, examined various parameters: fre-

quency of inspection; man hours of inspection

time; applicable GxP regulations; geographical

location of Sponsor; and reporting of findings.

The data showed that CLEH is audited by

Sponsors representing most continents of the

world, although perhaps as expected, the majority

of the auditors visiting are based in Europe, with

locally sourced consultants used by a number of

US-based Sponsors. Sponsor audit programmes

ranged from those requiring multiple inspections

annually, to others conducting reviews remotely.

S30 Poster Abstracts

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Generally, the larger global Sponsor companies

audit more frequently, and for longer, showing a

reasonable degree of correlation with the volume

of studies placed with us.

Keyword(s): Preclinical Research (GLP), Audit/

Inspection

Level: Basic (Suitable for professionals with less

than two years experience).

PP-6

The Quality Control of Preclinical Trials in

Russia

Maria A Zaytseva

The Institute of Toxicology Federal Medical

Biological Agency of Russia, St-Petersburg,

Russian Federation

Audit is a systematic and independent control of

the non-clinical study conducting. All preclinical

trials should be audited by the Quality Assur-

ance department of CRO.

QA have to ensure that the study has been

conducted in accordance with the local regula-

tions and GLP requirements.

The auditor should check personnel qualifica-

tion; vivarium; equipment; laboratory facility;

documentation; protocol, SOPs, GLP and local

regulations compliance; and tested article hand-

ling documentation.

Audits can be performed at any stage of the

study conduct but it is preferable to be

performed at the beginning of the study, to

minimize mistakes and deviations.

In the majority of cases in preclinical trails,

auditors deal with mistakes in documentation

completion – 30% cases; test article labelling

and storage – 9% cases; test article distributions

– 11% cases; equipment handling – 13%;

standard operation procedure execution –

20%; biosamples storage – 17% cases.

The best approach that could be recommended

for the Study Director to be prepared for any audit

is to strictly follow all protocol and regulatory

requirements from the beginning of the study and

meeting with an audit will only bring an

additional satisfaction and professional dividends.

Keyword(s): Preclinical Research (GLP), Audit/

Inspection

Level: Advanced (In-depth review of topic).

PP-7

Planning, Performing, Reporting Facility Audit

and Organizing CAPA: A Challenging Task for

QA in a GLP CRO

Labhu Sanghani

Jai Research Foundation, Vapi, Gujarat, India

The facility audit in the GLP CRO is an

important tool for continuous monitoring and

improvement of the quality systems in the

organization. A typical multifarious facility with

diversified scientific functions having highly

heterogeneous but convergent activities requires

an effective facility auditing system. The QA

facility audit involves advance planning of

various activities, departments coordinating with

the user and the dependent sections.

The facility audit could be broadly divided in

two types: 1. Vertical Audits and 2. Horizontal

audits.

The vertical audits cover every individual

section or department at appropriate predeter-

mined intervals to assure the compliance of the

facility to the GLP requirements.

The horizontal audits are performed by

selection of the common aspects in various

sections/departments in the organization.

The facility audit planning is undertaken to

cover both aspects of the audit. The QA should

consider the all the elements pertinent to the

facility under the audit plan for ensuring quality

systems. The important elements, which should

be covered include physical facility [labora-

tories, animal houses], personnel & training,

documents/documentation, safety, equipments,

chemicals, utilities, archives, pharmacy [test

substance control office] IT systems including

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servers as well as software packages, water, and

electrical supply systems, etc.

The audits should avoid the conflicts of

interest. QA must be able to identify the areas

and elements to be audited and identify the

observations/non compliance or other quality

issues. It is most advisable to establish an audit

specific checklist prior to the audit.

The facility audits require interaction between

auditor and auditee in detail, aimed at vertical

and lateral cross checking and evaluation. QA

must document the complete process and report

the finding with observations/non-compliance

and suggest the corrective action and preventa-

tive action (CAPA) to the Facility Management.

The corrective action and preventive action

should be documented and verified by QA

during the follow-up audit.

Keyword(s): Preclinical Research (GLP), Quality

Assurance

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-8

Significance of Effective QA Auditing and

Reporting System: Its Benefits to Pre-clinical

GLP Organizations

Labhu Sanghani

Jai Research Foundation, Quality Assurance

Unit, Vapi, Gujarat, India

The effective QA auditing and reporting system is

one of the critical key elements in the pre-clinical

GLP organization. The QA auditing and reporting

system includes various aspects of QA operations

viz., Facility audits, organization of Master

Schedule, audit schedule, selection of critical

phase(s), audit specific checklist, effective audit-

ing, timely reporting, follow-up audits & CAPA.

Jai Research Foundation, Quality Assurance

Audit Master (QAAM) is a validated database

management system, compatible with Window

9x operating system. The QAAM provides the

details on study based inspection as well as

facility inspection with specific details on audit

planning, audit status, QA observations and

information on QA auditors and Study Direc-

tors involved in the audits. The QAAM provides

daily report to Management on individual

studies in specific formats.

The QAAM is responsible for the QA state-

ments for individual studies with a list of audits

performed, reporting dates to Study Director

and Facility Management as well as the critical

phase of the specific study audit. The QAAM

provides the information, which is subjected to

regular trend analysis for identification of the

correction pathway. The QAAM monitors the

audit observations in various activities, regula-

tory areas and GLP aspects, in conformity with

the latest GLP requirements.

The QAAM helps Facility Management for

implementing and monitoring the effective Cor-

rective And Preventive Action (CAPA) program

in the organisation. The information flow

through the QAAM offers tremendous support

in raising the quality of research and reports. All

the critical functions involved in lab research e.g.

Study Directors; support functions interdepart-

mental coordination converts the organization

into a progressive GLP organization. The QAAM

is thus the eyes and ears of the Management

undertaking online study the quality indicators,

identifying the training needs or implementing

critical changes in the quality systems.

Keyword(s): Preclinical Research (GLP), Quality

Assurance

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-9

Multi-Site Toxicology Study Final Report Review

by a Testing Facility QAU: Great Expectations!

Willa Bailes*, Anita Bosau, Candance Brewer,

Matthew Bruns, Richard Clarke, Tracey Marquart,

Jennifer McGue, Judy Rable, Krista Richardson,

Deanna Talerico, Kevin Weitzel

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Charles River Laboratories, Preclinical Services,

Ohio, Spencerville, Ohio, United States

There is a systematic approach that can be

efficiently and effectively utilized by the Testing

Facility QAU when auditing a Multi-Site Tox-

icology final report as well as expectations of

what should be supplied by Test Sites to the

Testing Facility prior to approval and signature

of the final report.

Prior to Study Start

QA Acknowledgement Forms are sent to each

Test Site conducting portions of the study to

liaise with and provide the expectations for the

Test Site QAU during the study. Each Test Site is

requested to send a completed QA Acknowl-

edgement Form back to the Lead Testing Facility

QAU, including the appropriate QA contact

information for the Test Site.

During Study Conduct

* The Test Site QAU will provide the Study

Director results of critical phase inspections

and data/report audit findings.* Test Sites will provide the Study Director

deviation records so the impact of the

deviation on the study can be determined.

At Report Finalization

Records

* Verification that all required QA inspection/

audit records have been submitted to the

Study Director by each Test Site.* Verification that all deviations have been

submitted to the Study Director by the Test

Sites.

Report

* Verify that an individual scientist report has

been received, along with the appropriate

compliance statement and QA Statement.* Ensure that the archival location for all study

phases is included in the final report.

* Determine the extent of review for each

report based on risk assessment.

Conclusion

The great expectations can be fulfilled by clear

communication between the Testing Facility and

Test Sites. Quality Assurance plays an important

role in assuring all required components for a

toxicology study are included in the final report.

Keyword(s): Preclinical Research (GLP), Study

Reports

Level: Basic (Suitable for professionals with less

than two years experience).

PP-10

Integrating ISO 17025: 2005 Requirements in a

GLP Environment

Gretchen McAuliffe*, Jeanne Mensingh

EM2 Solutions, Inc., Pearland, Texas, United

States

The presence of a quality system is a critical

component to ensuring the accuracy of labora-

tory results. In regulated environments, GLPs

provide the organizational framework for the

conditions under which non-clinical laboratory

studies are planned, performed, monitored,

recorded, and reported. In analytical and cali-

bration laboratories, ISO 17025 accreditation is

becoming increasingly common because of the

strong technical principles it provides.

Because of the strengths each system imparts,

a growing trend is to implement ISO 17025

principles in a GLP environment. In addition,

laboratories providing GLP contract testing may

seek ISO 17025:2005 accreditation. Implemen-

tation of an ISO 17025 system in a GLP contract

laboratory provides a third party assessment of

the laboratory’s compliance with ISO 17025

standards and internal GLP SOPs.

This presentation will discuss common ele-

ments of GLP regulations and the ISO 17025

standard. In addition, differences between the

two systems will be discussed. This review will

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also provide a practical implementation plan for

ISO 17025 accreditation in a GLP laboratory.

Keyword(s): Preclinical Research (GLP), Good

Laboratory Practice (GLP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-11

Lean, Agile, and Compliant: Applying Agile

Techniques to Computer System Validation

Walter Townsend

TAP Pharmaceutical Products Inc., Electronic

Data Quality Assurance, Lake Forest, Illinois,

United States

In the Pharmaceutical Industry we most often

associate computer system validation with

cost, and plenty of it. Imagine a validation

approach that makes dollars by providing a real,

measurable return on investment (ROI) to an

organization, while also making good business

and quality sense. This presentation provides

strategies for applying agile software develop-

ment techniques to computer system validation

not only to reduce cost, but also to add

measurable value. By combining basic risk

management techniques with agile develop-

ment/validation processes, systems can be devel-

oped, validated and implemented more quickly;

users can be trained more effectively; and

regulatory compliance attained and maintained

at a lower cost.

Agile methods are adaptive. Unlike traditional

‘engineering’ methodologies, which are designed

to resist change, Agile methods adapt to, and

thrive on change. Agile methods also tend to be

people-oriented rather than process-oriented.

While engineering methods are designed to work

well no matter who executes the process, the

goal of Agile techniques is to establish a process

that supports the development team. This

presentation focuses on adapting these attributes

of Agile techniques to four key components of

software development activities: planning, re-

quirements gathering and analysis, testing, and

training.

Specific examples and strategies for integrat-

ing agile techniques in existing software devel-

opment lifecycle methodologies will be

described. Measures for cost and cycle-time

reduction, reduction in waste, reductions in

defects will be provided. Examples of results

will be included. Keys to successful implementa-

tion will be provided.

In conclusion, the presentation will demon-

strate that regulatory compliance can be

achieved more cost-effectively through the in-

tegration of agile techniques into existing quality

systems. Agile, lean, people-oriented processes

can be used to achieve compliance.

Keyword(s): Computer Validation, Computer

System

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-12

Validation Challenges of a Capitol Project:

Points to Consider

Jane Snell*

Charles River Laboratories, Wilmington,

Massachusetts, United States

Purpose: to describe the validation challenges of

a capital project and provide points to consider.

The success of a Capital Project Computer

System Validation effort hinges on many key

elements. Timely construction, adequately docu-

mented installation and commissioning of regu-

lated equipment and/or systems, and a

validation of those systems that is driven by a

policy and/or set of operating procedures that

detail a consistent process that is followed by all

individuals involved in the capital project.

Success is achieved when all individuals being

knowledgeable of the defined process are then

able to effectively manage and execute the

planned activities against that process in a

timely and cost effective manner.

S34 Poster Abstracts

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Success relies on competency of all individuals,

managerial authority not only to ensure response

to defined capital requirements, but also to

commit capital funds within the prescribed

limits. An adequate assembly of project teams

must be in place early and consistently main-

tained to execute project activities and schedules

and allow key decisions to be made quickly by

relevant participants and then communicated

throughout the team to ensure awareness,

adequate responses and/or execution.

Keyword(s): Computer Validation, Computer

System

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-13

Computer System Validation in GLP Environment

Somasundar Vajravelu

Clinigene Intl. Ltd., Documentation, Bangalore,

Karnataka, India

Background: To validate the computer systems

used for clinical studies and prove that the

mechanisms used to validate are meeting the

GLP, and all the Regulatory agencies require-

ments are adequate.

Purpose: This procedure describes the validation

of the approach and activities that will be

conducted during the installation of all the

computers and their accessories and document

the results needed to comply with GLP regulations.

Validation Plan: The validation plan applies to

the validation process and involves obtaining User

Requirement Specification (URS), Validation Pro-

tocol, Installation Qualification (IQ), Operation

Qualification (OQ) and Performance Qualifica-

tion (PQ) of computer servers, clients, peripherals

and accessories. Revalidation is to be performed

when there are any hardware/ software changes.

Responsibilities: User, IT, Department Head

and QA are to be detailed in validation plan.

Pre-installation Checks: Before the computer

systems arrive at the user’s laboratory, decide the

location, environment and space requirements

and specifications of installation of computer

systems.

Installation Procedure:

Steps during installation

Compare computer system as received with

purchase order (including software, accessories,

and spare parts), check equipment for any

damage, install computer hardware and periph-

erals, switch on the instruments and ensure that

all modules power up and perform an electronic

self-test, install software on computer, make

back-up copy of software and installation

verification files, configure peripherals, make a

list with description of all operating and

applications software installed on the computer

and prepare an installation report.

Operational Qualification Procedure: After

the installation, review and approve the IQ

report; an operational test will be followed a

process, which is referred to as Operational

Qualification (OQ).

During this qualification, some of the key

functions of the system are checked. System

booting; Check the access control; Check the

error messages; Data storage; Check the opera-

tions of peripherals; Check the status of the

Printer.

Risk Assessment: A risk analysis of all factors

including safety, environment, and product

quality should be taken into consideration.

Change Control: Any changes will be imple-

mented and documented by getting approval

with proper justification.

Maintenance and Support: Maintenance and

support activities will be provided by the IT

department or Vendor.

Contingency Planning and Disaster Recovery:

Contingency and disaster recovery activities will

be taken care of by IT department.

System Retirement: Before the computer

system will be taken out of service (decommis-

sioned) a system retirement plan and procedure

should be in place.

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Validation Documentation: Validation docu-

mentation includes an approved validation pro-

tocol and IQ, OQ, PQ reports, User manuals.

A summary of a validation report will be

prepared after the PQ test. The report comprises

the following: Summary of test results (IQ, OQ

and PQ), Change control details.

All the validation related documents will be

completed, get approved and all the documents

archived.

Conclusion: The above computer system valida-

tion procedure ensures that the validation

process meets the GLP principles of computer

system validation and other regulatory compu-

ter system validation requirements.

Keyword(s): Computer Validation, Computer

System

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-14

Computer Validation: A Practical Approach for

the GLP/GMP Environment

Jeanne Mensingh

EM2 Solutions, inc., Pearland, Texas, United

States

Guidelines and regulations for computer valida-

tion are vague and can lead to higher costs for

compliance. Many companies validate every-

thing at the same level. This may mean too much

validation or not enough. An approach based on

risk assessment will assist the company in the

development of levels of computer validation

requirements and the deliverables necessary for

documentation. These levels will result in in-

depth knowledge about the system and how

much validation is really required. This informa-

tion and the company’s philosophy for valida-

tion should be included in the master validation

plan.

This presentation will discuss the following:

* Master Validation Plan* Risk Assessment* Validation Deliverables* Requirements and Testing* The Summary Report

By approaching validation based on risk, the

company can save time and money.

Keyword(s): Computer Validation, 21 CFR part

11

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-15

Regulatory Concerns in Establishing Computer

Systems at Remote Sites

Anne Gagne

Charles River Preclinical Services Montreal Inc,

Quality Assurance, Senneville, Quebec, Canada

There are many challenges in setting up a remote

GLP facility. This poster will focus on those

challenges associated with the installation, opera-

tion and maintenance of computer systems at

such a site, whether it be within the same country

or across an ocean. The basic decision is whether

to host the applications at the main site or at the

remote site. This poster will walk through the

process, starting with gathering information from

end users (system owners) and ITS to the end

product, a facility with validated software sys-

tems for GLP data acquisition, analysis and

reporting. There are many factors which must

be taken into account, and each choice raises its

own difficulties and questions which must be

addressed. The intent of this poster is to look at

this from a regulatory aspect, without getting into

the technical details involved.

Keyword(s): Computer Validation, Preclinical

Research (GLP), Personal Development/Training,

Computer System

Level: Intermediate (Suitable for professionals

with more than two years experience).

S36 Poster Abstracts

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PP-16

The Importance of an Equipment Master

Inventory Management System for Effective

GLP Compliance

Labhu Sanghani

Jai Research Foundation, Vapi, Gujarat, India

A large and multifaceted organization has large

number of scientific instruments and equipment,

which may be subjected to daily or rare usage. It

is critical for these equipments to be identifiable,

maintained in top working conditions, and

periodically subjected to preventive maintenance

and calibration. A typical GLP facility manages a

plethora of equipment/instruments with varied

level of complicatedness, subjected to use in the

facility to meet the requirements of GLP. The well

documented records help the QAU to assure the

quality and integrity of data generated.

Jai Research Foundation, has evolved an in

house Equipment Master Inventory (EMI) system,

which answers various questions and provides the

information on thousands of equipments starting

from a simple micropipette, thermometers, volu-

metric flasks, balances, hot plates, water baths to

complex devices like computerized automated

systems related to chromatography, online facility

environmental data acquisition systems etc.

The EMI generates the information on Orga-

nization assets, occupancy level, workload,

calibration/validation and maintenance sche-

dules. The EMI provides the online information

to facility management, QA as well as the user

departments on availability of equipment, work-

ing status, calibration/maintenance schedule,

breakdown history and training needs. This

system helps to maximize usage, minimizing

the down time of the given equipment.

The EMI is an extremely powerful and useful

tool for the QA to keep track of various widely

scattered equipments using the online informa-

tion for planning the facility audits, tracking the

equipment history, development of audit checklist

and implementation of effective facility audits.

Keyword(s): Preclinical Research (GLP),

Equipment

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-17

Departmentalization Coordination: A Team

Approach

Barbara Randolph*, Pat Carver, Joe M. Fowler,

Melissa Hughes

Biotechnical Services, Inc., Mead, Washington,

United States

For most large laboratories, functional depart-

mentalization, i.e. grouping of activities by

functions performed, provides multiple advan-

tages by placing employees with technical

expertise and process experience into distinct

operational units throughout an organization.

However, separation of functional units can lead

to a loss of awareness of the diverse require-

ments that related departments must meet as

well as the overall corporate goal. As QAU

auditors or mock-agency inspectors, we often

see this illustrated during facility visits as

conflicting department SOP instructions, SOP

review deficiencies, overlooked SOP responsi-

bilities, lack of process understanding by study

personnel, and documentation of unnecessary

procedure deviations. To address the challenges

resulting from departmentalization, this poster

explores how to implement functional teams

and tools that cross over traditional department

lines to coordinate operational requirements.

Keyword(s): Preclinical Research (GLP),

Equipment

Level: Basic (Suitable for professionals with less

than two years experience).

PP-18

Overcoming the Challenges in the Immunogenicity

Assessment of Biotechnology-Derived Therapeutic

Proteins to Satisfy Regulatory Requirements

Jamil Hantash

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Poster Abstracts S37

Page 38: Abstracts of the Society of Quality Assurance 24th Annual Meeting

Millipore Corporation, St. Charles, Missouri,

United States

Biological/biotechnology-derived proteins are

increasingly used as therapeutic agents. It

has been recognised that these proteins

may induce cellular immune responses. The

consequences of an immune reaction to a

therapeutic protein range from transient appear-

ance of antibodies without any clinical signifi-

cance to severe life threatening conditions.

Potential clinical consequences are severe hyper-

sensitivity-type reactions, decrease in efficacy

and induction of autoimmunity, including anti-

bodies to the endogenous form of the protein.

Many factors may influence the immunogenicity

of therapeutic proteins. They can be considered

to be patient-, disease- or product-related.

Patient-related factors that might predispose to

an immune response include: underlying disease,

genetic background, immune status, including

immunomodulating therapy. Product-related

factors also influence the likelihood of an

immune response, e.g. intensity of treatment

(route of administration), source of protein,

manufacturing process (impurity profile, con-

taminants), formulation and stability character-

istics (degradation products, aggregates) of a

given protein and dose, dosing interval and

duration of treatment).

Early detection of immunogenicity reactions

is a key component of a drug develop-

ment program. Immunogenicity assays can

be challenged by lack of human positive controls

and ambiguity in choosing a meaningful

cut-point. We propose from a regulatory point

of view, a strategy for the balancing of the

dual detection system used in immuno-

genicity studies as well as the statistical

approach for the cut-point determination.

This approach allows the satisfaction of the

European and the North American regulatory

agencies.

Keyword(s): Biotechnology

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-19

A New Company Culture – Meeting the Challenges

of Establishing a Cell Culture Laboratory

Mazz Whitaker*, Karen Waetjen

Charles River Preclinical Services, Horsham,

Pennsylvania, United States

Important advancements in immunology and

biotechnology have necessitated an increasing

demand for cell culture studies in support of

preclinical safety assessment. QA’s role is key in

advising Testing Facility Management on the

appropriate steps and controls necessary to

minimize the potential for contamination.

Equally as important is the emphasis on

advanced training of facility, technical and

QAU personnel. This poster illustrates the

approach Charles River Laboratories, Preclini-

cal Services has taken to promote an under-

standing of how to identify potential regulatory

risks during construction, certification, opera-

tion and maintenance of a clean room facility.

Keyword(s): Biotechnology, Preclinical Research

(GLP), Personal Development/Training, Good

Laboratory Practice (GLP)

Level: Advanced (In-depth review of topic).

PP-20

The Keys to Good Documentation Practice

within a Regulated Environment

Cheryl McCarthy

Eliassen Group, eClinical Solutions Division,

Mansfield, Massachusetts, United States

Introduction: To provide techniques on

the management of documentation used

to support business critical and clinical

study requirements within a regulated environ-

ment. Focus will be on the sponsor manage-

ment of these documents; however these prac-

tices can be applied by a manufacturer or

clinical site.

Methods: Evaluate documentation used

for internal and external purposes and determine

S38 Poster Abstracts

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 39: Abstracts of the Society of Quality Assurance 24th Annual Meeting

elements that can be used to ensure:

* Identification of business critical and study

documentation* Key characteristics for a document are identified* Implementation of templates to provide con-

sistency in document formats* Documentation retention procedures are

managed* Good documentation editing practices are

employed* Appropriate versions of documents are being

used in practice* Access to documentation is available only to

authorized users

Results:

* Use of good documentation practices to

ensure legibility, attribution and timeliness

of business and study critical documentation* Consistency and standardization of documen-

tation, which allows documentation written

by different authors to look like they are

written by the same company* Proper identification and management of a

document from conception to retirement* More efficient audits (internal and external)

by managing consistent expectations through-

out the company that make documentation

more readable for auditors* Document versions are managed to ensure

that the most current information is being

used in practice* Documentation access is controlled

Discussion:

* Review of good documentation practices* Identify methods for implementation of good

documentation practices within a company –

i.e. Policy, Procedures, Work Instructions,

Forms, Training, Audit Checklists* Discuss options for managing conventions

used for draft and final versions of documents* Overview of different methods for retaining

and storing paper and electronic documents

and ensuring the documentation is accessible

to authorized users

* Discuss the impact of not following good

documentation practices as identified in FDA

warning letters and by participants audit

experiences

Keyword(s): Clinical Research (GCP),

Documentation

Level: Basic (Suitable for professionals with less

than two years experience).

PP-21

Clinical Trial Master Files – Remedies to QA

Observations

Cheryl Priest

Falcon Consulting Group, LLC, Exton,

Pennsylvania, United States

The conduct of Clinical Research studies in-

cludes extensive and detailed activities related to

the collection, organization and maintenance of

general study files and investigator-specific

documents. Unfortunately it appears that in-

dustry-wide efforts related to both initial and

ongoing quality control of individual documents

as well as overall file completeness and organi-

zation remain deficient and frequently result in

major findings during quality assurance audits.

Too often the files for a clinical study are left as a

final activity ending in crisis management clean-

up, organization and collection of missing

documents. What are the remedies to ensure

the integrity of Clinical Trial Master Files? Our

experience has shown that practical and logical

planning, diligent quality control procedures

and clearly defined document processing work-

flow will contribute to a solution. The appro-

priate application of new technologies for

document management, including document

tagging, scanning and electronic filing techni-

ques further supports the adequate and efficient

management of study files. This poster will

discuss important quality issues, study the

challenges of document management, and pro-

vide suggested mechanisms and initiatives for

quality management of Clinical Trial Master

Files.

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Poster Abstracts S39

Page 40: Abstracts of the Society of Quality Assurance 24th Annual Meeting

Keyword(s): Clinical Research (GCP),

Documentation

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-22

Novelties in the Regulation of Clinical Trials in

Latin America

Agueda Munoz del Carpio Toia*, Milena Toia

Larsen

CICA Santa Maria Catholic University and

Ethics Committee for the Clinical Research in

Latin America towns, Arequipa Peru, QUID

CONSULTING

The aim of this study is to describe the analysis

of the factors that influence the growth of the

clinical investigation in LATAM, taking as

example Peru’s case, for two reasons: Because

it has been approved its regulation of clinical

trials with high standards of quality and,

because it is considered one of the four countries

of LATAM with higher quantity of clinical trials.

The methodology used to know the reality of the

investigation in Peru was: the evaluation of

information coming from the Health National

Institute, which is the regulatory entity, the

analysis of the Peruvian new Regulation of

Clinical Research and, the interview of members

of Ethic’s Committees.

Results: Among the factors that influence

in the increment of clinical trials in Peru one has:

1. Some drugs in experimentation could be the

only available treatment alternatives in the

country, because not all the Peruvians have

access to a good health insurance and some

drugs are of high cost.

2. It is a country that has health care facilities

with high rates of patient’s enrolment.

3. There is access to diverse population groups

without previous treatments.

4. Illnesses that have been eradicated in devel-

oped countries persist.

5. The terms of the committees and of the

regulatory entity are smaller than in other neigh-

bouring regions and they can take few weeks.

6. New Ethics Committees have been imple-

mented as well as offices of diverse Contract

Research Organizations

7. Some sponsors carry out insurance of the

quality permanently in the investigation

facilities, etc.

8. The new Peruvian regulation of clinical trials

offers as norms the security for the subject of

investigation and it looks after the quality of

the data.

The results however show some problems that

wrap the clinical investigation in Peru. Mainly

training in specialized topics of investigation;

clinical; good clinical practices; audit; quality

assurance; bioethics; ethics committees; etc.

don’t exist.

Conclusions: The countries of LATAM have had

to adapt their norms and in other cases to

implement new norms to regulate the clinical

trials that guarantee the application of the good

clinical practices and the execution of the

international norm, to assure the well-being of

those subjects of investigation, as well as the

ethical and scientific quality of the investigation.

It can also be pointed out that all these efforts

are recognized by the sponsors and proof of it is

the growing investment and development of

multi-facilities investigations that includes Peru.

Peru is in the process of understanding that to

guarantee that if it complies with the pharma-

ceutical industry and with those subjects of

investigation with total quality, a new field of

international investment will be achieved and

one of development that brings progress, in-

vestigation opportunities and access to new

medications. The international collaboration

with appropriate respect of the good clinical

practices is also necessary in Peru. It should open

up quality assurance for sponsors, investigation

site and Independent ethics committees.

Keyword(s): Clinical Research (GCP), Clinical

Trials

S40 Poster Abstracts

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 41: Abstracts of the Society of Quality Assurance 24th Annual Meeting

Level: Basic (Suitable for professionals with less

than two years experience).

PP-23

Quality Assurance Programme in Clinical

Bioanalysis

Sundar Ganesan

Clinigene International Limited, QA, Bangalore,

Karnataka, India

Background: Determine a QA programme to

prove that the mechanisms used to assure the

Regulatory agencies and Management that

clinical bioanalysis studies conducted accor-

dance with GLP Principles are adequate.

Purpose/Objective: A Quality Assurance func-

tional programme in development and imple-

mentation of GLP in clinical bioanalysis

includes the following:

Monitoring Equipment Calibration, Equip-

ment Validation and Computer Systems Valida-

tion, Master Study Plan Maintenance, Database

Audits, SOP Management, Systems Audits,

Process Based Audits, Final Study Report Audit,

Vendor Evaluations, Cooperating and Escorting

Regulatory Inspections & Sponsor Inspections,

Quality Systems (ISO 9001:2000) Maintenance

and Corrective Action Implementation, Updat-

ing of training activities and records, EHS

Systems, Implementation and Monitoring GLP

Audits conducted by GLP Monitoring Agencies.

The Quality Assurance Programme is carried

out by an individual or by individuals designated

by management who are trained and familiar

with the test, quality procedures. The Quality

Assurance (QA) maintains the systems and the

methods for GLP inspections and monitoring of

clinical bioanalysis studies, and also recording of

observations made through QA monitoring. The

responsibilities of the Quality Assurance person-

nel include the following functions.

QA maintains master and issued copies of all

approved Study Plans and Standard Operating

Procedures in use in the test facility and have

access to an up-to-date copy of the master

schedule. Verification of the study plan contains

information required for compliance with Prin-

ciples of Good Laboratory Practice. This ver-

ification should be documented (Review of study

Protocols). Upon conducting of in-house GLP

inspection, decide that studies are conducted in

compliance with Principles of Good Laboratory

Practice. An inspection also determines that

study plans and Standard Operating Procedures

have been made available to study personnel and

are being followed. Three Types of GLP Inspec-

tions are carried out by QA in clinical bioana-

lysis: 1. Study-based inspections; 2. Facility-

based inspections; 3. Process-based inspections.

Records of such inspections should be retained.

QA should inspect the final study reports to

confirm that the methods, procedures, and

observations are accurately and completely

described, and that the reported results accu-

rately and completely reflect the raw data of the

Studies. QA should promptly report the inspec-

tion results in writing to Management and to the

Study Director. QA shall prepare and sign a

statement, which is to be incorporated with the

final report, which specifies types of inspections

and their dates, including the phase(s) of the

study inspected, the dates of inspection, dates

inspections results are reported to Management

and the Study Director/Principal Investigator.

Review, revision and updating of all SOPs with

respect to Quality System and studies are

conducted by QA.

QA in Clinical Bioanalysis develops and

implements all GLP norms with respect to

OECD and USFDA 21CFR Part 58 guidelines.

Conclusion: Clinical bioanalysis QA has a dual

role as internal Quality Control and as Quality

Assurance to guarantee the public that clinical

bioanalysis studies are performed by intended

techniques and to provide the valid, consistent,

integrated data. QA reports are distributed to the

Study Director and to the Management are

absolutely to be recorded as internal working

documents. QA reports are not for general

distribution and should be handled with discretion.

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Poster Abstracts S41

Page 42: Abstracts of the Society of Quality Assurance 24th Annual Meeting

Keyword(s): Bioanalysis, Good Laboratory

Practice (GLP)

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-24

Sample Size Calculation in Bioequivalence

Studies

Ramsathish S*, Balasubramanian L, Manoj VY

Clinigene International Limited, Bangalore, India

Aim

To get the smallest number of samples with high

power (80% or more), which establishes the

bioequivalence between the two formulations

within the clinically significant limits.

Methods

In a pilot study a minimum of 12 evaluable

subjects are required to establish the bioequiva-

lence for two products say ‘Test’ and

‘Reference’. Sufficient number of subjects should

be backed up for replacing drop outs, since

replacement of subjects during the study will

complicate the statistical model and analysis.

Dropouts should not be replaced.

However the sample size of the pivot study

will be estimated based on the coefficient

ofintra-subject variability obtained from pilot

study. There are several methods for determin-

ing the sample size.

Discussion

This article will discuss the procedure of sample

size calculation for 2X2 cross-over trials by

Chow & Liu and sample size calculation by S.

A. Julious.

Keyword(s): Bioanalysis, Biostatistics

Level: Intermediate (Suitable for professionals

with more than two years experience).

PP-25

RQAP-GCP, the Making of an Exam

Cheryl Bissey-Black

UCB, Inc., Smyrna, Georgia, United States

The purpose of this poster is to describe the

process entailed in creating a registration ex-

amination, specifically RQAP-GCP. Addition-

ally, it is the intent of the RQAP-GCP

Examination Committee that this poster will

create interest in not only the examination but

participation in the Examination Committee.

The poster will describe each process leading

to the execution of the registration examination.

Keyword(s): Clinical Research (GCP), Examination

Level: Intermediate (Suitable for professionals

with more than two years experience).

S42 Poster Abstracts

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 43: Abstracts of the Society of Quality Assurance 24th Annual Meeting

AUTHOR INDEX

Listed by Author and Abstract Number

These pages display all of the authors of the abstracts selected for the SQA 24th Annual Meeting with

the associated session and poster abstract numbers.

A

Ackerman, P DD-1

Aiello, P II-1

Anderson, R Y-1

Apraiz, I F-1, Y-2

Ault, J V-2

B

Bailes, W PP-9

Balasubramanian, L PP-24

Bardunias, J C-1

Bens, C F-1

Bissey-Black, C EE-1, PP-25

Bognar, C W-1

Bosau, A PP-9

Boyd, B PP-4

Brewer, C PP-9

Bridges, D F-1

Brodish, D B-2

Bruns, M PP-9

C

Calcagni, A C-1

Calvo, I F-1, Y-2

Carver, P PP-17

Clarke, R PP-9

Colligon, I G-2

Cooper, H DD-1

Cooper, J J-1

Curran, S W-2

D

Dallaire, L PP-2

Donegan, Theresa A E-1

Dutton, J PP-1

E

Eitzen, M F-1

Evans, K K-2

F

Fowler, J PP-17

Fulford, A PP-5

Furr, R R-2

G

Gagne, A PP-15

Garvin, D FF-1

Godwin, W I-1

Gordon, S S-1

Goreish, H Z-2

Ganeson, S PP-23

H

Haan, D I-1

Hamilton, K PP-5

Hancock, S B-1

Hantash, J PP-18

Hattemer-Apostel, R D-2, EE-2

Henry, R I-1

Hughes, M PP-17

Humes, E N-1

Huss, H BB-1

I

Iacono, N GG-1

K

Karau, J G-1

L

Liem, F Q-1

Litzenberger, B GG-1

M

Manoj, VY PP-24

March, C CC-1

Marquart, T PP-9

Marshall, M F-1

S43

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 44: Abstracts of the Society of Quality Assurance 24th Annual Meeting

McAulay, T PP-2

McAuliffe, G V-1, PP-10

McCarthy, C H-1, PP-20

McCullough, N C-1

McGue, J PP-9

McLean, L PP-2

Mensingh, J PP-10, PP-14

Moulaison, B O-1

Munoz del Carpio Toia, A PP-22

Myers, K PP-3

N

Nabors, J PP-1

O

O’Brien, J W-2

Olson, L BB-2

P

Patel, R L-1

Peischl, A V-3

Podraza, L D-1

Priest, C PP-21

R

Rable, J PP-9

Ramsathish, S PP-24

Randolph, B PP-17

Regehr, M E-2

Rhault, R C-1, S-1

Richardson, K PP-9

Runser, D DD-1

S

Sanghani, L PP-7, PP-8, PP-16

Schiff, K L-1

Schoeneman, H A-1

Siconolfi, R BB-3

Sidney, P O-2

Snell, J PP-12

Sower, L F-1

Straut, T P-1

Szczensy, S K-1

T

Talerico, D PP-9

Toia Larsen, M PP-22

Townsend, W PP-11

Triantafillou, L AA-1

V

Vajravelu, S PP-13

VanDevender, DA II-2

Vanterpool, I GG-1

Vilayphone, K G-3

W

Waetjen, K PP-19

Weitzel, K PP-9

Westbrook, T W-3

Westhoven, C N-1

Whitaker, M PP-19

Winter, M-H Z-1

Y

Yergler, J O-3

Z

Zaytseva, M PP-6

S44 AUTHOR INDEX

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.

Page 45: Abstracts of the Society of Quality Assurance 24th Annual Meeting

KEYWORD INDEX

Listed by Keyword and Abstract Number

These pages display the keywords of the abstracts selected for the SQA 24th Annual Meeting with

the associated session and poster abstract numbers.

21 CFR Part 11 BB-1, BB-2, BB-3, PP-14

Animal Health A-1, M-1, CC-1, FF-1

Audit/Inspection D-2, H-1, W-1, Z-1, GG-1,

II-1, II-2, PP-5, PP-6

Auditing II-1

Bioanalysis G-1, G-2, G-3, I-1, N-1,

X-1, PP-3, PP-4, PP-23,

PP-24

Biostatistics PP-24

Biotechnology CC-1, PP-18, PP-19

Chinese State FDA

GLP Regulations

O-2

Clinical QA Unit W-2

Clinical Research

(GCP)

D-1, D-2, H-1, J-1, L-1, N-

1, P-1, S-1, W-1, W-2, W-3,

AA-1, EE-1, EE-2, II-1, II-

2, PP-2, PP-20,

PP-21, PP-22, PP-25

Clinical Trials PP-22

Computer System PP-11, PP-12, PP-13, PP-15

Computer Validation C-1, E-1, E-2, R-2, BB-1,

BB-2, BB-3, PP-11, PP-12,

PP-13, PP-14, PP-15

Deviation

Investigation

G-1

Documentation PP-20, PP-21

Drug Deliver

Product Development

Z-2

Education/Training D-1, K-1, K-2

Electronic Signature R-2

Equipment PP-16, PP-17

Examination PP-25

Food and Drug

Administration

Z-1

GHTF Z-1

Good Clinical

Practice (GCP)

T-1, EE-1

Good Laboratory

Practice (GLP)

B-1, E-1, Q-1, U-1, PP-19,

PP-23

GLP Research

Conducted in China

O-2

Good Manufacturing

Practice (GMP)

G-2, V-1, V-2, V-3, Y-1,

DD-1

Good X Practice

(GXP,

multidisciplinary)

N-1, Y-2

Harmonization Z-1

Health Canada Z-1

Human Subject

Protection

AA-1

Internal Systems

Audits

W-3

Investigations G-1

Licensing Due

Diligence

S-1

Management F-1, Y-2

Manufacturing (GMP) S-1, V-1, V-2, V-3, Z-1,

DD-1, PP-4

Medical Devices J-1, Z-1, Z-2, PP-4

Method

Development/

Validation

I-1

Multisite Studies FF-1, PP-2

New Drug

Application (NDA)

CC-1

Personal

Development/

Training

K-1, K-2, GG-1, PP-2,

PP-3, PP-15, PP-19

Preclinical Research

(GLP)

E-1, G-1, G-2, G-3, I-1,

J-1, O-1, O-2, O-3, S-1,

FF-1, GG-1, PP-2, PP-4,

PP-5, PP-6, PP-7, PP-8, PP-

9, PP-10, PP-15,

PP-16, PP-17, PP-19

Protocols FF-1

Quality PP-1, PP-2

Quality Assurance C-1, G-3, O-3, PP-4, PP-7,

PP-8

Quality Metrics O-1, EE-2, PP-1, PP-2,

PP-3

Quality Policy B-2

Risk Management C-1, L-1, P-1

Software E-2

Study Reports PP-9

University/Academic

Research

B-1, B-2, F-1, Y-1, Y-2

S45

Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.