An Integrated Approach to Analytical Instrument Qualification (AIQ) and Computerised System Validation (CSV) for the GMP Regulated Laboratory

SPEAKERS:

Dr Christopher BurgessBurgess Analytical Consultancy, UK

Dr Bob McDowallMcDowall Consulting, UK

PROGRAMME:

� Analytical Equipment Qualification: Where Are We Now?

� Computerised System Validation: Where Are We Now?

� AIQ and CSV: A Risk-based Approach � An Integrated Approach to AIQ and

CSV: – Process Workflows – How to Minimise the Validation/ Qualification Effort

– Key Documents to be Written – Component Installation – User Configuration – User Acceptance Testing

� Applying Integrated Approach Principles in Practice to

– Analytical Balance – Stand Alone Spectrometer – HPLC with a Networked CDS Data System

Integrating Analytical Instrument Qualification and Computerised System Validation

27 – 28 October 2014, Copenhagen, Denmark

Participate in 6 Workshops!

This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“

Learning Goals

Analytical instrumentation used within GMP analytical labo-ratories is computerised either via firmware inside the instru-ment or via a workstation with software loaded on to a work-station that is situated next to the instrument. However, the current situation regarding the qualification of analytical in-strumentation and validation of computerised systems is un-satisfactory; qualification and validation are typically con-sidered as separate activities with little if any interaction between the two disciplines.

For example, the AAPS have produced guidance on analytical instrument qualification (AIQ) that has been incorporated as General Chapter <1058> within the United States Pharmaco-poeia (USP). This focuses on the instrument with little em-phasis on computerised system validation. In contrast, the GAMP Good Practice Guide for Validation of Laboratory Computerised Systems looks exclusively on the computer-ised system and ignores the instrument qualification aspects entirely.

The major problem is that you cannot validate the computer system without qualifying the instrument and vice versa.

The teaching team have been actively involved in bringing AIQ and CSV together during 2011 - 3: they have written a stimulus for revision paper for USP <1058> that was published in the January-February 2012 issue of Pharmacopoeial Forum. Also they have been involved with input and writing sections of the second edition of the GAMP Good Practice Guide for Validation of Laboratory Computerised Systems published in November 2012. In addition they have redrafted USP <1058> and are co-authors of an article published in Pharmaceutical Engineering mapping the GAMP and USP <1058> approaches together. The course will include material from these publi-cations. In addition there is now the new version of Annex 11 in com-bination with Chapter 4 in Europe: what is the impact of these regulations on laboratory systems?

This workshop will address these current concerns and present an integrated approach to analytical instrument qual-ification (AIQ) and computerised system validation (CSV) for laboratory systems including the latest information with USP and GAMP. This will be achieved by presentations coupled with workshops and discussions to reinforce the presentation principles. The number of participants is limited.

Note: This workshop will not discuss directly user training and the writing of SOPs for operating the instruments or systems.

Target Group

Analytical scientists, laboratory managers, validation per-sonnel working with laboratory equipment and systems, quality assurance personnel and any IT personnel involved with systems such as chromatography data systems and LIMS.

Programme

Introduction to the Course � Aims and objectives of the course � Course process (presentations / workshops) � Road map for the course

A Risk-based Approach - Working Smarter not Harder � Quality Management Systems in the analytical labora-tory; implications of ICH Q10

� Traditional approaches to calibration, qualification & validation

� Impact of new technology changes on instruments & systems

� New and novel regulatory expectations � Equipment, Apparatus, Instrument or System? � Establishing ‘fitness for purpose’ and ‘suitability for intended use’

� Terms and definitions; the role of a technical glossary

Analytical Instrument Qualification: Where Are We Now? � Calibration or Qualification?; Modular & holistic ap-proaches

� USP <1058> Analytical Instrument Qualification � USP <1058> Stimulus to the revision process paper � Establishing risk-based criteria based on user ways of working

� Software linking in USP <1058> now and future: the new sub groups proposed

� Applying the principles of USP <1058> in practice to an – Analytical balance – Stand alone spectrometer – HPLC with a networked CDS data system

Computerised System Validation: Where Are We Now? � Regulators

– FDA; Part 11, Predicate Rules & 2002 software validation guidelines – EU; the New Annex 11 and Chapter 4 requirements – PIC/S Good practices for computerised systems in regulated “GXP” environments

� Industry – GAMP 5: risk based approach – GAMP Good Practice Guides: Laboratory computerised systems 2nd Edition

� Applying CSV principles to – Analytical balance – Stand alone spectrometer – HPLC with a networked CDS data system

An Integrated Approach to AIQ and CSV for Analytical Systems – Part 1

� Do I have to qualify or validate? � The new USP <1058> proposed risk assessment process:

– Define intended purpose – Record impact – Software classification – System categorisation

� If I do how much do I do?

Integrating Analytical Instrument Qualification and Computerised System Validation 27 – 28 October 2014, Copenhagen, Denmark

An Integrated Approach to AIQ and CSV for Analytical Systems – Part 2

� How can I minimise the validation/qualification effort? � Threads and Phases of the Integrated Model of AIQ & CSV

� Applying integrated approach principles to – Analytical balance – Stand alone spectrometer – HPLC with a networked CDS data system

Documenting the Qualification and Validation Effort � How much do I really need to do? � Key documents to be produced � “Validation Lite” a simplified approach for low risk systems

� Paper or electronic documentation � Traceability of the validation/qualification effort � Supporting documentary evidence � Managing sign off and operational release � Linking with a Quality Management System (QMS)

Component Installation and Integration � Nomenclature & mapping; the USP <1058> 4 Qs & GAMP

� Factory acceptance testing; strengths and weaknesses � Vendor documentation; pros & cons � Vendor installation & commissioning � Leveraging vendor activities to reduce user testing � Configuration management and the change control baseline

� Managing the IT interface � Applying the principles to

– Analytical balance – Stand alone spectrometer – HPLC with a networked CDS data system

Configuring the Application to Meet User Needs � Establishing laboratory work flows & SOPs � How good is the fit with vendor materials? � Prototyping to determine/ensure the fit to the business process

� Defining mandatory user requirements as a conse-quence of the workflow

� Operational ranges & conditions � Calibration procedures and reference standards � Do you need a configuration document for

– Analytical balance, – Stand alone spectrometer, – HPLC with a networked CDS data system?

� What are the implications for change control?

User Acceptance Testing – Instrument, Software and System

� What to test and what not to test � What has the vendor to offer? � Risk assessment and the URS � Typical aspects to test � Test plans and test scripts

WORKSHOP IIRisk Assessment with Process Workflows – Exploring the Integrated Approach to AIQ and CSVAn integrated approach for qualifying instruments and validating software will use the proposed <1058> risk assessment for three examples: .

� Analytical Balance � Stand alone spectrometer � HPLC with a networked CDS data system

This will be working in teams.

WORKSHOP IRisk Assessment of Laboratory Instruments and Systems – Application of the Proposed <1058> Risk AssessmentAttendees will be given a short inventory with intended use defined and taken through the proposed <1058> risk assessment to classify the instruments and systems. This will be facilitated group work.

WORKSHOP IIITurning the Principles of the Integrated Approach into PracticeAttendees will be given three examples and asked to adapt the integrated AIQ – CSV process for each one:

� Analytical Balance � Stand alone spectrometer � HPLC with a networked CDS data system

WORKSHOP IVRisk Assessment of Vendor IQ and OQ DocumentationAttendees will review examples of vendor qualification documentation from the examples below to identify where time can be saved or where there is little value add from the vendor approach:

� Analytical balance � NIR spectrometer � Networked CDS

WORKSHOP VDocumenting the User ConfigurationThe attendees will identify where user configuration is required for a real life scenario of an implementation of an automated dissolution system connected to an automated HPLC and networked data system.

� Assumptions exclusions and limitations of testing � White box and black box testing � Testing approaches � Setting sound acceptance criteria � Integrating calibration and qualification

Speakers

Dr Christopher BurgessBurgess Analytical Consultancy, Barnard Castle, UKDr Burgess is a Chartered Chemist and has more than 40 years experience in the pharma-ceutical industry primarily with Glaxo in Qual-

ity Assurance and Analytical R&D. He is a “Qualified Person” and a member of the European QP Association advisory board. He has been appointed to the United States Phar-macopoeia’s Council of Experts 2010 to 2015 and is a visiting professor of the University of Strathclyde’s School of Phar-macy and Biomedical Sciences (SIPBS). In addition, he is the chairman of the ECA Analytical Quality Control Group and a member of the Executive committee of European Compli-ance Academy.

Dr Bob McDowallMcDowall Consulting, Bromley, Kent, UKAnalytical chemist with over 40 years experi-ence including 15 years working in the phar-maceutical industry; Principal of McDowall Consulting, UK for over 20 years. He has been

involved with the validation of computerised systems for over 25 years and is the author of a book on the validation of chromatography data systems. Bob is the writer of the Questions of Quality (LC-GC Europe) and Focus on Quality (Spectroscopy) columns and is a member of the Editorial Advisory Boards of several Journals.

Moderator

Dr Bob McDowall, McDowall Consulting, UK

Social Event

At the evening of the first course day all participants and speakers are invited to a dinner in a nice restaurant, where the topics of the course can be further dis-cussed in a relaxed atmosphere.

ECA Education CourseFDA-Compliance in Analytical Laboratories 29-31 October 2014

On 29 - 31 October 2014, i.e. from Wednesday to Friday of the same week, there will be another ECA GMP Education Course in Copenhagen about FDA Compliance in Analytical Laboratories. The objec-tive of this course is to give the participants com-prehensive insight into the key laboratory compli-ance issues for laboratories in an FDA-regulated environment.

Topics that will be covered are:

� Regulatory Requirements and FDA Inspections � Documentation in the Pharmaceutical Quality Control

� Sampling in Compliance with FDA Requirements � Qualification of Analytical Instruments in the QC � Calibration for FDA Inspected Analytical Labora-tories

� Reference Standards and Reagents for FDA-inspected Laboratories

� Validation of Analytical Procedures � Stability Testing � Out of Specification Results � Practical Computer Validation in Analytical Labo-ratories

� Transfer of Analytical Procedures � Validation of Excel Spreadsheets � Training Case Study

In addition, Workshops are offered about:

� Method Validation � Out of Specification Results � Validation of Excel-Spreadsheets � Method Transfer

Speakers:Dr Manfred Fischer, SkyePharma AG, SwitzerlandDr Christopher Burgess, Burgess Analytical Consultancy, UKDr Joachim Ermer, Sanofi, GermanyDr Bob McDowall, McDowall Consulting, UK

The course on Integrating Analytical Instrument Qualification and Computerised System Valida-tion (27 - 28 October 2014) is an ideal precursor to the Education Course FDA-Compliance in Analyti-cal Laboratories (29 -31 October 2014). Further in-formation about the course FDA-Compliance in Analytical Laboratories can be received at www.gmp-compliance.org.

Participants who register simultaneously for both courses will receive a 350€ discount (not valid for EU GMP Inspectorates).

WORKSHOP VIHow to Focus on Critical Areas for User Acceptance TestingBased on the outputs from workshop 5, the attendees will decide how to focus on the critical areas of the sys-tem for user acceptance testing.

Organisation and Contact

CONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 Heidelberg,GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Dr Günter Brendelberger (Operations Director) at +49-62 21 / 84 44 40, or per e-mail at brendelberger@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.:Ms Marion Weidemaier (Organisation Manager) at +49-62 21 / 84 44 46, or per e-mail at weidemaier@concept-heidelberg.de

What are The ECA Foundation and the ECA Academy?

The European Compliance Academy Foundation (ECA Founda-tion) is an independent professional organisation chaired by a Scientific Advisory Board with members from the pharmaceuti-cal industry and regulatory authorities. The ECA Foundation’s goal is to support to the Pharmaceutical Industry and Regula-tors to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and inter-pretation of new or updated guidances. The ECA Academy of-fers professional basic and advanced education (training) pro-grammes. All services offered by the ECA Academy and with regard to ECA Academy Memberships are solely managed by Concept Heidelberg (a leading European training and informa-tion services provider). The ECA Foundation is conceptual sponsor of the ECA Academy.

How Do You Become a Member of ECA?

By participating in one of the ECA Academy Conferences or Courses you will automatically become a ECA Academy Indi-vidual Member for two years - free of charge. More information about ECA Academy can be obtained on the Website http://www.gmp-compliance.org

What Are the Benefits of ECA?

During the membership, you enjoy a € 200,- discount on the regular partici-pation fee of any European Conference or Course presented by the ECA Acad-emy. In addition you will receive the GMP Guideline Manager Software with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines.

Lufthansa is Mobility Partner for all ECA Events

As an ECA course or conference attendee, you will receive up to 20% discounted travel fares (ac-cording to availability). And as

Lufthansa German Airlines offers a comprehensive global route network linking major cities around the world you will most likely be able to benefit from these special prices and condi-tions.

And this is how it works: Once you registered for a course or conference you will receive a link together with your registra-tion confirmation. Opening that link will take you to the Mobil-ity Partner Program website where you can enter a code in the “Access to Event Booking” area you will also receive. This will take you into an online booking platform* that will automati-cally calculate the discount offered or provide you with an even better offer if another promotional fare is available.

We look forward to welcoming at one of our next events – and we already wish you a pleasant flight!

*Please note: You may have to enable pop-ups on the Mobility Partner Program website – other-wise the booking platform window will not open.

GMP Certification Programme

This seminar is recognised within the GMP Certification Pro-gramme. By attending selected seminars, the participant can acquire an additional certificate. We offer the following certification modules:

� ECA Certified Validation Manager � ECA Certified QA Manager � ECA Certified API Production Manager � ECA Certified Quality Control Manager � ECA Certified Technical Operations Manager � ECA Certified Computer Validation Manager � ECA Certified Regulatory Affairs Manager � ECA Certified Microbiological Laboratory Manager � ECA Certified Sterile Production Manager � ECA Certified Biotech Manager � ECA Certified Pharmaceutical Development Manager

On the internet at www.gmp-compliance.org you will find a text explaining which seminars are recognised for which certificates.

Or you send an e-mail to info@gmp-compliance.org or a fax to +49-6221-84 44 64 with the request for informa-tion about the GMP Certification Pro-gramme. We will then send you our brochure on the topic.

wa/vers1/19022014

Date

Monday, 27 October 2014, 09.00 - 18.30 h (Registration and coffee 08.30 – 09.00 h)Tuesday, 28 October 2014, 08.30 - 17.00 h

Venue

Radisson BLU Scandinavia HotelAmager Boulevard 702300 Copenhagen SDenmarkPhone +45 33 96 50 00Fax +45 33 96 55 55

Fees*

ECA Members € 1,490,- APIC Members € 1,590,- Non-ECA Members € 1,690,- EU GMP Inspectorates € 845,- The course fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have reg-istered for the event. Please use this form for your room reservation to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel. Early reservation is recommended.

Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference language

The official conference language will be English.

*per delegate plus VAT

If you register for the ECA Education Course “FDA Compliance in Analytical Laboratories” from 29-31 October 2014 at the same time, you will receive a 350 € discount. This is not valid for EU GMP Inspectorates.

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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

#

SPEAKERS:

Dr Christopher BurgessBurgess Analytical Consultancy

Dr Joachim ErmerSanofi

Dr Manfred FischerSkyePharma

Dr Bob McDowallMcDowall Consulting

LEARNING OBJECTIVES:

� FDA Inspections � cGMP Compliant Documentation � Analytical Instruments

– Qualification according to USP <1058> – Calibration – Computer Validation

� Practical Ways to Validate Excel Spreadsheets

� Reference Standards: a Risk-based Life Cycle Approach

� Analytical Methods – Validation – Method Transfer

� Out-of-Specification Results – FDA OOS Guidance

� Training Case Study � Stability Testing

29 - 31 October 2014, Copenhagen, Denmark

FDA Compliance inAnalytical Laboratories

How to implement cGMP requirements in theeveryday practice of quality control laboratories.

4 Interactive Workshops

This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“. Please find details at www.gmp-certification.eu

Objectives

The purpose of this three-day education course is to give participants a comprehensive overview of FDA’s current compliance requirements (21 CFR Part 211, Guidances for Industry, Compliance Program Guide, etc.) and ex-pectation in these and related areas, and how they can be managed effectively.

The format allows each of our speakers to give an over-view of the specific regulatory requirements associated with their topic prior to describing the approach to man-aging the issues with respect to philosophy, documented procedures, SOPs, etc.

In addition, the programme includes four workshop sessions covering:

� Method Validation � Out of Specification Results � Validation of Excel Spreadsheets � Method Transfer

The course will also discuss the implication of new developments resulting from recent FDA initiatives.

Background

A major consequence of the Barr Ruling in 1993 was the significantly greater emphasis FDA inspections placed on the management and performance of quality control lab-oratories, and particularly the handling of Out of Specifi-cation results.

As a result of the increased and on-going scrutiny of ana-lytical performance it is hardly surprising that even today the most frequently cited cGMP non-compliances are still found in laboratories, particularly:

� General cGMP understanding and particularly relating to compliance with written procedures

� Validation, performance and transfer of analytical procedures

� Equipment qualification and calibration � Computer validation (including the requirements and

actual interpretation of 21 CFR Part 11) � Operator training

Take advantage of this course to discuss all these issues.

Target Group

This course will be of significant value to: � All quality control managers responsible for FDA

compliance in their laboratories � Senior laboratory staff charged with meeting these

requirements day-to-day � All support staff involved in FDA inspections in their

companies

Programme

General Aspects: Regulatory Requirements and FDA Inspections

� Regulatory requirements (cGMP, CFR, Guidances for Industry, etc.)

� FDA Inspections � Quality System Inspections (QSIT) � Key issues during laboratory inspections � 483s and Warning Letters � FDA’s ‘Pharmaceutical cGMPs for the 21st Century: A

Risk-based Approach’ Initiative � ‚Process Analytical Technology‘ (PAT) initiative

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Qualification of Analytical Instruments in the QC � Legal requirements (cGMP, CFR, etc.) � USP General Chapter <1058> Analytical Instrument

Qualification � Qualification Phases (DQ/IQ/OQ/PQ) � Case study: Qualification of a NIR-spectrophotometer

– NIR Monograph: USP vs. EP – Change Control

� Analytical instrument life-cycle (Requalification, etc.)Dr Manfred Fischer, SkyePharma, Switzerland

Calibration for FDA Inspected Analytical Laboratories � Requirements in the USP for instrument calibration � Contrasting US and European approaches (important

in the context of laboratories struggling to meet both requirements)

� ISO Guide 17 025 requirementsDr Christopher Burgess, Burgess Analytical Consultancy, UK

Reference Standards and Reagents for FDA-Inspected Laboratories

� Regulatory requirements � Official/primary/working standards � Traceability of standards � Purity and characterisation of reference standards � Handling, storage and shelf-life of reference standards

and reagents � Documentation

Dr Joachim Ermer, Sanofi, Germany

Validation of Analytical Procedures � Regulatory requirements (ICH, FDA,compendia) � Holistic validation approach � Rationale design of validation studies � Relevant performance parameters � Sensible use of statistics

Dr Joachim Ermer, Sanofi, Germany

FDA Compliance in Analytical Laboratories

29 - 31 October 2014, Copenhagen, Denmark

Stability Testing � Stability testing of drug substances and drug products � Stability testing for NDAs, ANDAs, and INDs � Stability protocol � Reporting stability data � Specific stability requirements � Stability testing for post-approval changes

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Out of Specification Results � Requirements of the FDA Guidance � Efficient laboratory investigations � Reanalysing, retesting, resampling � Handling of atypical results

Dr Joachim Ermer, Sanofi, Germany

Documentation for Quality Control Laboratories � “Scientifically sound” GMP requirements of QC

documents and approaches � Types of QC laboratory documents:

– Test specifications – Standard Operating Procedures – Instrument qualification protocols – Complete data for analytical testing and

Certificates of Analysis � Compare and contrast FDA and EU documentation

requirementsDr BOB McDOWALL, McDowall Consulting, UK

Sampling in Compliance with FDA Requirements � Importance of the sampling procedure � Regulatory requirements � Sampling statistics / sampling plans � Sampling procedures � Sampling equipment and environment � Training � Retained samples

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Practical Computer Validation in Analytical Laboratories

� Computerised system validation as a critical activity in the analytical laboratory

� 21 CFR Part 11 compliance � FDA emphasis on data integrity for computerised

systems � GAMP® software categories and impact on validation

approach � GAMP Good Practice Guide for Validation of Labora-

tory Systems second edition � Case study examples: how to validate systems in a

cost effective way and steps of what not to do! � Validation Lite for low risk systems

Dr Bob McDowall, McDowall Consulting, UK

FDA Approaches to Laboratory Data Integrity � FDA laboratory observations: falsification and fraud � Compliance Program Guide 7346.832 on Pre-Approv-

al Inspections: Objective 3 - Laboratory data integrity � FDA inspector training: focus on the computer system

not paper printouts

Dr BOB McDOWALL, McDowall Consulting, UK

Four Workshops

Some of the most important laboratory compliance topics will be further discussed in interactive work-shops:

Topic I: Method ValidationModerator: Dr Joachim Ermer

Topic II: Out of Specification ResultsModerator: Dr Christopher Burgess

Topic III: Validation of Excel SpreadsheetsModerator: Dr Bob McDowall

Topic IV: Method TransferModerator: Dr Manfred Fischer

Transfer of Analytical Procedures � USP General Chapter <1224> Transfer of Analytical

Procedures (TAP) � Key steps for a successful method transfers:

– Initiation phase (training method familiarization, etc.) – Types of transfer – Analytical procedures – Materials (samples and standards) and testing design – Instruments – Data assessment – Acceptance criteria – Documentation (transfer protocol / report)

� SummaryDr Manfred Fischer, SkyePharma, Switzerland

GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5

Validation of Excel Spreadsheets � Excel spreadsheets are used widely in analytical

laboratories as it is easily available and easy to use – and equally so, it is easy to misuse

� Technical features available in Excel 2007 � Practical ways to validate Excel spreadsheets � Protection of the electronic records produced � Problems of complying with 21 CFR Part 11 and the

new EU GMP Annex 11 RequirementsDr Bob McDowall, McDowall Consulting, UK

Training Case Study � Legal requirements � Education / GMP training / Training on the job � Training records � Re-training frequency

Dr Manfred Fischer, SkyePharma, Switzerland

Literature

Each participant will receive the following together with the conference material:

� FDA’s Human Drug cGMP Notes (including the parts that are not available via Internet)

� The complete BARR Ruling

Integrating Analytical Instrument Qualification and Computerised System Validation

On 27 - 28 October 2014, i.e. on Monday and Tues-day of the same week, there will be another ECA GMP Education Course in Copenhagen about Inte-grating Analytical Instrument Qualification and Computerised System Validation. The course is an ideal precursor to the Education Course FDA-Compliance in Analytical Laboratories (29 - 31 October 2014). Further information about this course can be received at www.gmp-compli-ance.org.

Participants who register simultaneously for both courses will receive a 350 € discount (not valid for EU GMP Inspectorates).

Social Event

On the evening of the first course day all participants and speakers are invited to a guided sight seeing tour and a nice dinner afterwards.

Moderator

Dr Christopher BurgessBurgess Analytical Consultancy, UK

Speakers

Dr Christopher BurgessChartered Chemist with more than 36 years experience in the pharmaceutical industry pri-marily with Glaxo in Quality Assurance and Analytical R & D. He is a “Qualified Person”

and a member of the European QP Association advisory board. He has been appointed to the USP Council of Ex-perts 2010 to 2015.

Dr Joachim ErmerHead of Quality Control Services Chemistry, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany and Global Reference Standards Coordinator of Sanofi. Over 20 years of

experience in pharmaceutical analytics in development, industrial, and global functions. He has been appointed to the USP Validation and Verification Expert Panel 2010- 2012.

Dr Manfred FischerHead Analytical Department / Quality Control at Skye-Pharma, Basel (Switzerland). Responsi-ble for development, validation / transfer of analytical methods and quality control of clini-

cal trial material.

Dr Bob McDowallAnalytical chemist with over 40 years experi-ence including 15 years working in the phar-maceutical industry; Principal of McDowall Consulting, UK.

GAMP® is a trademark of ISPE - http://www.ispe.org/gamp5

Organisation and Contact

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64 69007 Heidelberg, Germany Phone +49-62 21/84 44-0Fax +49-62 21/84 44 84info@concept-heidelberg.de, www.concept-heidelberg.de

For questions regarding content:Dr Günter Brendelberger (Operations Director) at +49-62 21 / 84 44 40 or per e-mail at brendelberger@concept-heidelberg.de.For questions regarding reservation, hotel, organisation etc.:Ms Marion Weidemaier (Organisation Manager) at +49-62 21 / 84 44 43 or per e-mail at weidemaier@concept-heidelberg.de.

What are The ECA Foundation and the ECA Academy?

The European Compliance Academy Foundation (ECA Foundation) is an independent professional organisation chaired by a Scientific Advisory Board with members from the pharmaceutical industry and regulatory authori-ties. The ECA Foundation’s goal is to support to the Phar-maceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guide-lines by providing information and interpretation of new or updated guidances. The ECA Academy offers profes-sional basic and advanced education (training) pro-grammes. All services offered by the ECA Academy and with regard to ECA Academy Memberships are solely managed by Concept Heidelberg (a leading European training and information services provider). The ECA Foundation is conceptual sponsor of the ECA Academy.

How Do You Become a Member of ECA?

By participating in one of the ECA Academy Conferences or Courses you will automatically become a ECA Academy Individual Member for two years - free of charge. More informa-tion about ECA Academy can be ob-tained on the Website http://www.gmp-compliance.org

What Are the Benefits of ECA?

During the membership, you enjoy a EUR 200,- discount on the regular participation fee of any European Confer-ence or Course presented by the ECA Academy. In addi-tion you will receive the GMP Guideline Manager Soft-ware with a large number of guidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines.

GMP Certification Programme

This seminar is recognised within the GMP Certification Programme for the module “Certified Quality Control Manager”. By attending selected seminars, the partici-pant can acquire an additional certificate. We offer the following modules:

� ECA Certified Validation Manager � ECA Certified QA Manager � ECA Certified API Production Manager � ECA Certified Quality Control Manager � ECA Certified Technical Operations Manager � ECA Certified Computer Validation Manager � ECA Certified Regulatory Affairs Manager � ECA Certified Microbiological Laboratory Manager � ECA Certified Sterile Production Manager � ECA Certified Biotech Manager � ECA Certified Pharmaceutical Development Manager

On the Internet at www.gmp-compliance.org you will find a text explaining which seminars are recognised for which certificates. Or you send an e-mail to info@gmp-compliance.org or a fax to +49-6221- 84 44 64 with the request for information about the GMP Certification Pro-gramme. We will then send you our brochure on the topic.

Special offer with Lufthansa – up to 20% discounted travel for all ECA Events Attendees

As an ECA course or confer-ence attendee, you will receive up to 20% discounted travel fares (according to availability).

And as Lufthansa German Airlines offers a comprehen-sive global route network linking major cities around the world you will most likely be able to benefit from these special prices and conditions.

And this is how it works: Once you registered for a course or conference you will receive a link together with your registration confirmation. Opening that link will take you to the Mobility Partner Program website where you can enter a code in the “Access to Event Book-ing” area you will also receive. This will take you into an online booking platform* that will automatically calcu-late the discount offered or provide you with an even better offer if another promotional fare is available.

We look forward to welcoming at one of our next events – and we already wish you a pleasant flight!

*Please note: You may have to enable pop-ups on the Mobility Partner Program website – other-wise the booking platform window will not open.

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Wednesday, 29 October 2014, 09.00 h - 18.30 h(Registration and coffee 08.30 h - 09.00 h)Thursday, 30 October 2014, 08.30 h - 18.30 hFriday, 31 October 2014, 08.30 h - 15.30 h

Venue

Radisson BLU Scandinavia HotelAmager Boulevard 702300 Copenhagen S, DenmarkPhone: +45 33 96 50 00Fax: +45 33 96 55 55

Do you want to save money?If you register for the ECA Education Course “Integrating Analytical Instrument Qualification and Computerised System Validation” from 27 to 28 October 2014 at the same time, you will receive a 350 € discount. This is not valid for EU GMP Inspectorates.

Fees (per delegate plus VAT)

ECA Members € 1,790APIC Members € 1,890Non-ECA Members € 1,990EU GMP Inspectorates € 995The conference fee is payable in advance after receipt of invoice and includes conference doc-umentation, dinner on the first day, lunch on all days and all refreshments. VAT is reclaimable.

Accommodation

CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the event. Please use this form for your room reservation to receive the specially negotiated rate for the duration of your stay. Reservation should be made directly with the hotel. Early reservation is recommended.

Registration

Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Conference Language

The official conference language will be English.

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4 Easy Registration

Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org