ISPE Conference on Product and Process Quality

Applying GAMP 5 Risk-based Approaches in Practice

Wednesday 17- Thursday 18 September 2008
Manchester, United Kingdom

Seminar Leaders:
Sion Wyn, Conformity Ltd (UK)
Peter Robertson, Retired, AstraZeneca (UK)

• Address the practical concepts and approaches described in GAMP 5
• Receive an update on the re-examination of FDA 21 CFR Part 11
• Discuss and analyse the proposed revision of EU Annex 11

This seminar will provide delegates with current thinking and examples on how the risk-based approaches described in GAMP 5 may be applied in practice. The sessions will demonstrate that the specification, design, implementation, operation, and subsequent retirement of a computerised system require careful planning and organisation within a structured framework. If managed correctly, this not only ensures compliance with Regulatory requirements but also enables technological advance and encourages innovation.

The seminar will offer the first opportunities for the industry to present and discuss the impact of GAMP 5 and how it is being put into practice. It will also cover two pieces of legislation that are likely to appear in the near future – EU Annex 11 and the Revised 21 CFR Part 11. 

Take Back To Your Job:

• Understand the GAMP 5 approach to quality risk management
• Understand the impact of ICH Q9 and Q10
• Relate risk-based concepts to the use of computerised systems and the data they manage
• Discover ways in which the GAMP approach can apply these concepts to enable innovation
• Discuss major updates to important regulations such as EU Annex 11 and 21 CFR Part 11


Agenda

Wednesday, 17 September

09.30 – 09.45 Welcome and Introduction
Siôn Wyn, Conformity Ltd. (UK); Peter Robertson, AstraZeneca (UK)

09.45 – 10:30 GAMP®5 - Putting Principles Into Practice
Guy Wingate, GlaxoSmithKline (UK)

  • Key concepts
  • Practical Implementation
  • Impact of GAMP 5
  • Looking forward

10.30 – 11.00 Coffee and networking break

11.00 – 11.45 Current Status of Annex 11 and Chapter 4
Karl-Heinz Menges, Regierungspräsidium Darmstadt (Germany)

11.45 – 12.30 Industry views on Annex 11 and Chapter 4 proposals
Siôn Wyn, Conformity Ltd. (UK)

  • Up to date comment from industry on the proposed revisions
  • Analysis of views: synergy and divergence
12.30 – 14.00 Lunch and networking break

14.00 – 15.30 Workshop 1: Benchmarking Compliance and Validation Activities
Kate Samways, KAS Associates (UK); David Selby, Selby-Hope International Ltd. (UK)

  • Benchmarking current life-cycle status
  • Addressing the gaps
15.30 – 16.00 Coffee and networking break

16.00 – 16.45 Case Study 1: GAMP®5 Risk-based Implementation of an R&D Training Records Database
Chris Clark, Napp (UK)

  • Implementing and qualifying to meet Regulatory and business needs
  • Designing the testing strategy based upon the assessment and management of risk
  • Improving the upgrade process by leveraging vendor knowledge and reappraisal of risks
  • Use of metrics to monitor project performance
16.45 – 17.15 Feedback from Workshop
Kate Samways, KAS Associates (UK); David Selby, Selby-Hope International Ltd. (UK)

17.15 – 18.30    Networking Reception                  

 

Thursday, 18 September

09.00 – 09.15 Review of Day 1 - Introduction of Day 2
Siôn Wyn, Conformity Ltd. (UK); Peter Robertson, AstraZeneca (UK)

09.15 – 10.00 Case Study 2: ERP Systems - Moving from 'Tight definition' to Risk-based across a Global Organisation
Speaker to be confirmed

  • Maintaining flexibility in requirements
  • Efficiency in testing
  • Leveraging suppliers capability

10.00 – 10.45 Case Study 3: An EBRS Implementation using GAMP®5 principles
Tineke Bos, Astellas (Netherlands); Philip Rees, CTP System (Italy)

  • Model use of EBRS in production, with interfaces to SAP, LIMS, Trackwise
  • URS structured according to business process
  • Focus on scientific risk assessment using HACCP method and risk mitigation for GMP and the business
  • Batch record review by exception and signed electronically

10.45 – 11.15 Coffee and networking break

11.15 – 12.00 Case Study 4a: Risk Management Approach to the Design and Enforcement of a Corporate Quality Management System
Heather Watson, GlaxoSmithKline (UK)

  • Who is involved in designing the system?
  • What processes are involved?
  • Documentation required for implementation

12.00 – 12.45 Case Study 4b: Risk Management Approach to the Design and Enforcement of a Corporate Quality Management System
Thomas Fuchs, Novartis (Switzerland)

  • Design of QMS to address known corporate risks
  • Embodying risk management within a corporate QMS
  • Risk aligned enforcement of the corporate QMS - driving the audit programme

12.45 – 14.15 Lunch and networking break

14.15 – 15.00 Workshop 2: Applying GAMP®5 Principles to a Cross-Function Application Supporting Both GxP and non-GxP Business Processes
Winnie Cappucci, Bayer Healthcare (USA)

  • Identification of regulated business processes
  • Identification of processes impacting on patient safety, product quality and data integrity
  • Scaling of life cycle activities

15.00 – 15.45 Case Study 5: Application of QRM to Periodic Review and Disaster Recovery Testing
Karen Alexander, Pfizer (UK)

  • Developing a risk-based methodology to determine frequency and depth of periodic review and putting it into practice
  • Determining the frequency and scope of DR testing and putting into practice
  • Benefits of using these approaches and the lessons learned

15.45 – 16.00 Questions & Answers – Chair’s Seminar close
Siôn Wyn, Conformity Ltd. (UK); Peter Robertson, AstraZeneca (UK)