A GAMP Interpretation - Annex 11

A detailed and comprehensive GAMP interpretation of the new revised EU GMP Annex 11 has been produced by a core GAMP CoP Task Team of industry experts, and reviewed by the GAMP CoP Council and members of GAMP Regional Steering Committees. Annex 11 defines EU requirements for computerised systems, and applies to all forms of computerised systems used as part of GMP regulated activities. This is a major revision, which has a significant impact on all GMP regulated companies. The webinar explains the GAMP interpretation of key requirements, and how Annex 11 can be met in a pragmatic and effective way. The focus will be on the critical areas currently generating most discussion throughout industry. At the conclusion of this session, participants will be able to:

  • Explain the GAMP interpretation of the requirements
  • Understand how Annex 11 can be met in a practical manner

This webinar gives invaluable information about international regulatory expectations for computerized systems compliance and validation with an official GAMP interpretation.

Presenter Biography

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He is currently assisting the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP®5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated healthcare industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.



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