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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.
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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* 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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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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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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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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
* 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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Presentation Abstracts S11
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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).
Presentation Abstracts S15
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
S22 Presentation Abstracts
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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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
S24 Presentation Abstracts
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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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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-
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
Poster Abstracts S27
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
Poster Abstracts S29
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
Poster Abstracts S31
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
S32 Poster Abstracts
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
Poster Abstracts S33
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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.
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
Poster Abstracts S35
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
Copyright r 2008 John Wiley & Sons, Ltd. Qual Assur J 2008; 12, S1–S45.
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
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.
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
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.
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
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.
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.
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.
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.