ISPE Conference on Product and Process Quality

Science and Risk-based Approach for C&Q: Application of the new Baseline Guide

Monday 15- Tuesday 16 September 2008
Manchester, United Kingdom

Seminar Leaders:
Nuala Calnan, Project Management Group Ltd (Ireland)
Robert Adamson, Foster Wheeler Energy Ltd (UK)

• Find out how to transition from the original C&Q Baseline® Guide to the ASTM Standard
• Align the Guide with GAMP® Guides, ISPE Technical Documents and ISPE’s PQLI initiative
• Listen to case studies on transitioning from the original Guide for both new and legacy systems

This seminar offers an exclusive opportunity to receive an overview of the Baseline® Pharmaceutical Engineering Guide for Installation and Verification – An Implementation Guide in Support of Science and Risk-based approaches for C&Q and In Support of ASTM E2500, which is currently in development.

The new guide will coexist with the current C&Q Baseline Guide and provides guidance on the implementation of risk-based approaches and verification of a system under the ASTM Standard E2500 – Standard for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. The seminar also focuses on how the new Guide incorporates concepts from ICH Q8 and Q9 guidance, and provides procedures to improve delivery of regulated manufacturing capacity.

This is a topic of great interest to the industry as the ASTM E2500 standard was published in 2007 and delegates will be interested to understand more about ISPE’s response. It is also of major significance due to the ongoing debate as to whether the previous guide and methodology are to be followed or whether the industry should move to this new paradigm.

Take Back To Your Job:
• Thorough knowledge of ASTM E2500 and its impact on Commissioning and Qualification
• Transition historical practice into the implementation of the ASTM Standard
• Understand the application to the legacy system lifecycle
• Show alignment with GAMP, other ISPE technical documents, and ISPE’s PQLI initiative
• Identify and control risks in the manufacturing process
• Understand Regulatory perspectives

Agenda

Monday, 15 September

09.30 - 09.45 Introduction & Welcome by Seminar Leaders
Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland)

09.45 - 10.30 Introduction to the New Guide for Verification (Commissioning and Qualification for ASTM E2500)
David Petko - Auxillium Pharmaceuticals Inc. (USA) - Chair, Baseline Guide Team

Overview and history of the revision of Guide
Link to old Guide – Revised publication strategy
Introduction to the new Guide

10.30 - 11.00 New Baseline^® Guide Overview, Continued
Steve Wisniewski, IPS (USA)

Outline of the Key Concepts of the Science and Risk-based Approach

11.00 - 11.30 New Baseline^® Guide Overview, Continued
Petter Gallon, AstraZeneca (Sweden)

Risk Management principles and application

11.30 - 12.00 New Baseline^® Guide Overview, Continued
Joerg Block, Bayer HealthCare AG (Germany)

Verification Concept and new lifecycle outlined

12.00 - 13.00 Lunch and networking break

13.00 - 13.45 Review of Industry Comments
Guy Wingate, GlaxoSmithKline (UK) - Co-chair Baseline Guide Team

Overview of level of industry comments received through the publication process and the editorial responses to those comments in the New Baseline Guide

13.45 - 14.30 Integration with GAMP^®5
Siôn Wyn, Conformity Ltd (UK)

Integration of new verification guide concepts with GAMP 5 and GAMP Good Practice Guides ( VPCS/ Calibration)

14.30 - 15.00 Coffee and networking break

15.00 - 15.45 Product Quality Lifecycle Initiative (PQLI)
Bruce Davis, AstraZeneca (UK) - Chairman, ISPE

Introduce PQLI concept and how the science and risk-based perspective relate back to ICH

15.45 - 16.30 Regulatory Presentation
Speaker to be confirmed

European Regulators view on Risk Based approaches
European Regulators view specifically on the ASTM 2500-07 standard
Expectations of applications of ICH Risk Based Approaches as relevant to C&Q

16.30 - 17.00 Discussion Panel
Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland); David Petko - Auxillium Pharmaceuticals Inc. (USA); Steve Wisniewski, IPS (USA); Petter Gallon, AstraZeneca (Sweden); Joerg Block, Bayer HealthCare AG (Germany); Guy Wingate, GlaxoSmithKline (UK); Siôn Wyn, Conformity Ltd (UK); Bruce Davis, AstraZeneca (UK) - Chairman, ISPE

17.00 Seminar Close

Networking Reception

Tuesday, 16 September

09.00 - 10.15 Good Engineering Practices (GEP)
Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland)

Introduction to GEP as a philosophy
Overview core concepts and common practices of a GEP program
Explore the ability of a well devised GEP program to impact and influence outcomes right across the project lifecycle
Practical application examples of critical GEP activities required at the different lifecycle phases

10.15 - 10.45 Coffee and networking break

10.45 - 11.15 Change Management and Design Review
Steve Wisniewski, IPS (USA)

Continuation and application of core concepts relating to application of
Change Management Principles
Design Review Practices

Transitional Case Studies of Risk Based Approaches

11.15 - 12.00 Case Study 1: Risk Based Integrated ICV Approach and lessons learned - Eli Lilly Biopharm
Richard Ryrie, Eli Lilly (UK)

12.00 - 12.45 Case Study 2: Implementation of ASTM E2500– A full Scale Project Prospective
Peter Werner Christensen, NNE Pharmaplan (Denmark)

12.45 - 13.45 Lunch and networking break

13.45 - 14.30 Case Study 3: Biopharmaceutical Facility - Achieving a Successful Campus Start-up
Jonathan Sowerbutts, Centocor Biologics (Ireland)

14:30-15:15 Case Study 4: Integrated Verification of Automation and Mechanical Equipment
Joerg Block, Bayer HealthCare AG ( Germany)

15.15 - 16.00 Case Study 5: Application of Risk Management Tools for the introduction of a new Combinational Drug Product into an existing Medical Devices Facility
Timothy Howard, Commissioning Agents Inc. (USA)

16.00 - 16.30 Discussion Panel
Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland); Steve Wisniewski, IPS (USA); Richard Ryrie, Eli Lilly (UK); Peter Werner Christensen, NNE Pharmaplan (Denmark); Jonathan Sowerbutts, Centocor Biologics (Ireland); Joerg Block, Bayer HealthCare AG ( Germany); Timothy Howard, Commissioning Agents Inc. (USA)

16.30 Seminar Ends – Chair’s Close
Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland)


Conference Programme General Information Hotel Information Networking Evening Sponsorship Opportunities Table Top Exhibitions Download Brochure	ISPE Conference on Product and Process Quality Science and Risk-based Approach for C&Q: Application of the new Baseline Guide Monday 15- Tuesday 16 September 2008 Manchester, United Kingdom Seminar Leaders: Nuala Calnan, Project Management Group Ltd (Ireland) Robert Adamson, Foster Wheeler Energy Ltd (UK) • Find out how to transition from the original C&Q Baseline® Guide to the ASTM Standard • Align the Guide with GAMP® Guides, ISPE Technical Documents and ISPE’s PQLI initiative • Listen to case studies on transitioning from the original Guide for both new and legacy systems This seminar offers an exclusive opportunity to receive an overview of the Baseline® Pharmaceutical Engineering Guide for Installation and Verification – An Implementation Guide in Support of Science and Risk-based approaches for C&Q and In Support of ASTM E2500, which is currently in development. The new guide will coexist with the current C&Q Baseline Guide and provides guidance on the implementation of risk-based approaches and verification of a system under the ASTM Standard E2500 – Standard for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. The seminar also focuses on how the new Guide incorporates concepts from ICH Q8 and Q9 guidance, and provides procedures to improve delivery of regulated manufacturing capacity. This is a topic of great interest to the industry as the ASTM E2500 standard was published in 2007 and delegates will be interested to understand more about ISPE’s response. It is also of major significance due to the ongoing debate as to whether the previous guide and methodology are to be followed or whether the industry should move to this new paradigm. Take Back To Your Job: • Thorough knowledge of ASTM E2500 and its impact on Commissioning and Qualification • Transition historical practice into the implementation of the ASTM Standard • Understand the application to the legacy system lifecycle • Show alignment with GAMP, other ISPE technical documents, and ISPE’s PQLI initiative • Identify and control risks in the manufacturing process • Understand Regulatory perspectives Agenda Monday, 15 September 09.30 - 09.45 Introduction & Welcome by Seminar Leaders Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland) 09.45 - 10.30 Introduction to the New Guide for Verification (Commissioning and Qualification for ASTM E2500) David Petko - Auxillium Pharmaceuticals Inc. (USA) - Chair, Baseline Guide Team Overview and history of the revision of Guide Link to old Guide – Revised publication strategy Introduction to the new Guide *10.30 - 11.00 New Baseline^® Guide* Overview, Continued** Steve Wisniewski, IPS (USA) Outline of the Key Concepts of the Science and Risk-based Approach *11.00 - 11.30 New Baseline^® Guide* Overview, Continued** Petter Gallon, AstraZeneca (Sweden) Risk Management principles and application *11.30 - 12.00 New Baseline^® Guide* Overview, Continued** Joerg Block, Bayer HealthCare AG (Germany) Verification Concept and new lifecycle outlined 12.00 - 13.00 Lunch and networking break 13.00 - 13.45 Review of Industry Comments Guy Wingate, GlaxoSmithKline (UK) - Co-chair Baseline Guide Team Overview of level of industry comments received through the publication process and the editorial responses to those comments in the New Baseline Guide 13.45 - 14.30 Integration with GAMP^®5 Siôn Wyn, Conformity Ltd (UK) Integration of new verification guide concepts with GAMP 5 and GAMP Good Practice Guides ( VPCS/ Calibration) 14.30 - 15.00 Coffee and networking break 15.00 - 15.45 Product Quality Lifecycle Initiative (PQLI) Bruce Davis, AstraZeneca (UK) - Chairman, ISPE Introduce PQLI concept and how the science and risk-based perspective relate back to ICH 15.45 - 16.30 Regulatory Presentation Speaker to be confirmed European Regulators view on Risk Based approaches European Regulators view specifically on the ASTM 2500-07 standard Expectations of applications of ICH Risk Based Approaches as relevant to C&Q 16.30 - 17.00 Discussion Panel Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland); David Petko - Auxillium Pharmaceuticals Inc. (USA); Steve Wisniewski, IPS (USA); Petter Gallon, AstraZeneca (Sweden); Joerg Block, Bayer HealthCare AG (Germany); Guy Wingate, GlaxoSmithKline (UK); Siôn Wyn, Conformity Ltd (UK); Bruce Davis, AstraZeneca (UK) - Chairman, ISPE 17.00 Seminar Close Networking Reception Tuesday, 16 September 09.00 - 10.15 Good Engineering Practices (GEP) Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland) Introduction to GEP as a philosophy Overview core concepts and common practices of a GEP program Explore the ability of a well devised GEP program to impact and influence outcomes right across the project lifecycle Practical application examples of critical GEP activities required at the different lifecycle phases 10.15 - 10.45 Coffee and networking break 10.45 - 11.15 Change Management and Design Review Steve Wisniewski, IPS (USA) Continuation and application of core concepts relating to application of Change Management Principles Design Review Practices Transitional Case Studies of Risk Based Approaches 11.15 - 12.00 Case Study 1: Risk Based Integrated ICV Approach and lessons learned - Eli Lilly Biopharm Richard Ryrie, Eli Lilly (UK) 12.00 - 12.45 Case Study 2: Implementation of ASTM E2500– A full Scale Project Prospective Peter Werner Christensen, NNE Pharmaplan (Denmark) 12.45 - 13.45 Lunch and networking break 13.45 - 14.30 Case Study 3: Biopharmaceutical Facility - Achieving a Successful Campus Start-up Jonathan Sowerbutts, Centocor Biologics (Ireland) 14:30-15:15 Case Study 4: Integrated Verification of Automation and Mechanical Equipment Joerg Block, Bayer HealthCare AG ( Germany) 15.15 - 16.00 Case Study 5: Application of Risk Management Tools for the introduction of a new Combinational Drug Product into an existing Medical Devices Facility Timothy Howard, Commissioning Agents Inc. (USA) 16.00 - 16.30 Discussion Panel Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland); Steve Wisniewski, IPS (USA); Richard Ryrie, Eli Lilly (UK); Peter Werner Christensen, NNE Pharmaplan (Denmark); Jonathan Sowerbutts, Centocor Biologics (Ireland); Joerg Block, Bayer HealthCare AG ( Germany); Timothy Howard, Commissioning Agents Inc. (USA) 16.30 Seminar Ends – Chair’s Close Robert Adamson – Foster Wheeler (UK); Nuala Calnan – PM Group (Ireland)