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ISPE GAMP® 5: A Risk Based Approach to Compliant GxP Computerized Systems (Second Edition),1
Sion Wyn
Conformity Ltd.
Director
Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance, data integrity, electronic records and signatures, and international regulations in this field. He assisted the FDA as a consultant with its re-examination of 21 CFR Part 11 and was a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He received the FDA Group Recognition Award for work on Part 11. Wyn was co-lead of the GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition, and the ISPE GAMP Guide - Record and Data Integrity, and is a member of the ISPE GAMP Global Steering Committee, and GAMP Editorial Board. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical industry. He received the ISPE UK Fellow Award in 2016.
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