VPCS - Validation of Process Control Systems – A Major Revision of the GAMP^® Guide

3–4 December 2008
Barcelona, Spain

Seminar Leaders
Mark Cherry, AstraZeneca (UK)
Hilary Mills-Baker, CEL International Ltd (UK)

Essential knowledge on the latest principles and approaches in VPCS
In-depth review of the revised ISPE GAMP Guide for Validation of Process Control Systems
Understand the role of VPCS in implanting new technologies and harmonising existing approaches

This seminar is intended to provide delegates with the latest principles, concepts and approaches to the validation of process control systems. The seminar will provide details on how the planned revision to the GAMP Good Practice Guide for the Validation of Process Control Systems will incorporate the principles in the recently published GAMP 5 Guide, and harmonise with other related Good Practice Guides, including "A Risk-based Approach to Compliant ERES", "Testing of GxP Systems" and the updated C&Q Baseline^® Guide.

Using a lifecycle approach to VPCS risk management issues, speakers will identify core issues including project management, governance procedures, operational approaches and supplier assessment. Additionally, speakers will review supporting processes, from change control to documentation management.

As a result, the seminar offers a full programme of useful information for delegates who regularly use ISPE’s VPCS Good Practice Guide or who seek structure and guidance on implementing efficient processes into their existing systems.

Take Back to Your Job

New and updated information on the content of the GAMP Good Practice Guide for Validation of Process Control Systems
Insights on how this approach may be applied in practice across a range of system types
A better understanding of the importance of validated process control systems in supporting the successful implementation of new approaches like PAT

Agenda

Wednesday, 3 December

10.00 – 10.15 Welcome and Introduction
Mark Cherry, Astra Zeneca (UK)

10.15 – 10.30 VPCS Overview
Hilary Mills-Baker, CEL International (UK)

VPCS background
Principles used in the revision
New VPCS document structure

10.30 – 11.15 GAMP 5 Overview
Sion Wyn, Conformity Ltd (UK)

Key principles
Science-based quality risk management
Overview of the lifecycle approach
Introduction to verification
Leveraging supplier activities

11.15 – 13.00 VPCS Risk Management
Mark Cherry, Astra Zeneca (UK)
Karen Ashworth, Karen Ashworth Consulting Ltd (UK)

Principles of risk management for process control
Risk management within the lifecycle
Link to ICH Q8&9
Principles of scalability across a range of examples
Practical workshop

13.00 – 14.00 Lunch and Networking Break

14.00 – 15.00 Project Phase of Lifecycle
Sue Tuxford, Emerson Process Management (UK)
David James, Invensys (UK)
George Smerdon, Industrial Technology Systems Ltd UK)
Hilary Mills-Baker, CEL International (UK)

Overview of validation planning
Specification and review with workshop

15.00 – 15.15 Coffee and Networking Break

15.15 – 17.15 Project Phase of Lifecycle (continued)
Sue Tuxford, Emerson Process Management (UK)
David James, Invensys (UK)
George Smerdon, Industrial Technology Systems Ltd UK)
Hilary Mills-Baker, CEL International (UK)

Coding and configuration with workshop
Reporting and release

17.15 – 17.45 Questions and Answers, Close of Day 1
Hilary Mills-Baker, CEL International (UK)

17.30 – 18.30 Networking Reception

Thursday, 4 December

09.00 – 09.15 Introduction to Day 2
Hilary Mills-Baker, CEL International (UK)

09.15 – 10.00 C&Q Baseline Guide Update
Speaker to be confirmed

Alignment to E2500
Linkage to Good Engineering Practice
Harmonising with VPCS

10.00 – 11.00 Project Phase of Lifecycle (continued)
Gerhard Werling, Rockwell (Germany)
Reetu Chopra, Jacobs (tbc)

Verification activities
Test stages
Linkage to risk assessment
Practical workshop

11.00 – 11.15 Coffee and Networking Break

11.15 – 11.45 Governance
Mark Cherry, Astra Zeneca (UK)

Policies and procedures
Roles and responsibilities
System inventory
Managing supplier relationships

11.45 – 12.45 Operations and Retirement
Brian Nolan, Schering-Plough (Ireland)

System security
Incident management
Business continuity
Periodic review
Legacy systems
Data migration

12.45 – 14.00 Lunch and Networking Break

14.00 – 15.00 Supplier Assessment
Malcolm Knott, Industrial Technology Systems Ltd (UK)

Assessment techniques
Scope and scalability of assessment activities
Leveraging supplier documentation
Workshop

15.00 – 15.45 Supporting Processes
Hilary Mills-Baker, CEL International (UK)
Sue Tuxford, Emerson Process Management (UK)
Mark Cherry, Astra Zeneca (UK)

Change control
Configuration management
Documentation management workshop

15.45 – 16.15 Questions and Answers, Close of Seminar
Mark Cherry, Astra Zeneca (UK)


Conference Programme General Information Venue and Area Information Networking Evening Sponsorship Opportunities Table Top Exhibition Registration Information Download Brochure Current as of 18 August Delegates See the company and country background of already registered delegates !	VPCS - Validation of Process Control Systems – A Major Revision of the GAMP^® Guide 3–4 December 2008 Barcelona, Spain Seminar Leaders Mark Cherry, AstraZeneca (UK) Hilary Mills-Baker, CEL International Ltd (UK) Essential knowledge on the latest principles and approaches in VPCS In-depth review of the revised ISPE GAMP Guide for Validation of Process Control Systems Understand the role of VPCS in implanting new technologies and harmonising existing approaches This seminar is intended to provide delegates with the latest principles, concepts and approaches to the validation of process control systems. The seminar will provide details on how the planned revision to the GAMP Good Practice Guide for the Validation of Process Control Systems will incorporate the principles in the recently published GAMP 5 Guide, and harmonise with other related Good Practice Guides, including "A Risk-based Approach to Compliant ERES", "Testing of GxP Systems" and the updated C&Q Baseline^® Guide. Using a lifecycle approach to VPCS risk management issues, speakers will identify core issues including project management, governance procedures, operational approaches and supplier assessment. Additionally, speakers will review supporting processes, from change control to documentation management. As a result, the seminar offers a full programme of useful information for delegates who regularly use ISPE’s VPCS Good Practice Guide or who seek structure and guidance on implementing efficient processes into their existing systems. Take Back to Your Job New and updated information on the content of the GAMP Good Practice Guide for Validation of Process Control Systems Insights on how this approach may be applied in practice across a range of system types A better understanding of the importance of validated process control systems in supporting the successful implementation of new approaches like PAT Agenda Wednesday, 3 December 10.00 – 10.15 Welcome and Introduction Mark Cherry, Astra Zeneca (UK) 10.15 – 10.30 VPCS Overview Hilary Mills-Baker, CEL International (UK) VPCS background Principles used in the revision New VPCS document structure *10.30 – 11.15 GAMP 5* Overview** Sion Wyn, Conformity Ltd (UK) Key principles Science-based quality risk management Overview of the lifecycle approach Introduction to verification Leveraging supplier activities 11.15 – 13.00 VPCS Risk Management Mark Cherry, Astra Zeneca (UK) Karen Ashworth, Karen Ashworth Consulting Ltd (UK) Principles of risk management for process control Risk management within the lifecycle Link to ICH Q8&9 Principles of scalability across a range of examples Practical workshop 13.00 – 14.00 Lunch and Networking Break 14.00 – 15.00 Project Phase of Lifecycle Sue Tuxford, Emerson Process Management (UK) David James, Invensys (UK) George Smerdon, Industrial Technology Systems Ltd UK) Hilary Mills-Baker, CEL International (UK) Overview of validation planning Specification and review with workshop 15.00 – 15.15 Coffee and Networking Break 15.15 – 17.15 Project Phase of Lifecycle (continued) Sue Tuxford, Emerson Process Management (UK) David James, Invensys (UK) George Smerdon, Industrial Technology Systems Ltd UK) Hilary Mills-Baker, CEL International (UK) Coding and configuration with workshop Reporting and release 17.15 – 17.45 Questions and Answers, Close of Day 1 Hilary Mills-Baker, CEL International (UK) 17.30 – 18.30 Networking Reception Thursday, 4 December 09.00 – 09.15 Introduction to Day 2 Hilary Mills-Baker, CEL International (UK) *09.15 – 10.00 C&Q Baseline Guide* Update** Speaker to be confirmed Alignment to E2500 Linkage to Good Engineering Practice Harmonising with VPCS 10.00 – 11.00 Project Phase of Lifecycle (continued) Gerhard Werling, Rockwell (Germany) Reetu Chopra, Jacobs (tbc) Verification activities Test stages Linkage to risk assessment Practical workshop 11.00 – 11.15 Coffee and Networking Break 11.15 – 11.45 Governance Mark Cherry, Astra Zeneca (UK) Policies and procedures Roles and responsibilities System inventory Managing supplier relationships 11.45 – 12.45 Operations and Retirement Brian Nolan, Schering-Plough (Ireland) System security Incident management Business continuity Periodic review Legacy systems Data migration 12.45 – 14.00 Lunch and Networking Break 14.00 – 15.00 Supplier Assessment Malcolm Knott, Industrial Technology Systems Ltd (UK) Assessment techniques Scope and scalability of assessment activities Leveraging supplier documentation Workshop 15.00 – 15.45 Supporting Processes Hilary Mills-Baker, CEL International (UK) Sue Tuxford, Emerson Process Management (UK) Mark Cherry, Astra Zeneca (UK) Change control Configuration management Documentation management workshop 15.45 – 16.15 Questions and Answers, Close of Seminar Mark Cherry, Astra Zeneca (UK)

VPCS - Validation of Process Control Systems – A Major Revision of the GAMP® Guide

3–4 December 2008 Barcelona, Spain

Agenda

VPCS - Validation of Process Control Systems – A Major Revision of the GAMP^® Guide

3–4 December 2008
Barcelona, Spain