Mr. Sion Wyn

Director, Conformity Ltd.

Sion Wyn, Director, Conformity Ltd., is an acknowledged international expert in computer system validation and compliance. He was consultant to US FDA during the re-examination of 21 CFR Part 11, and a core member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11. Wyn is a GAMP founder member, Editor of the ISPE GAMP 5 Guide A Risk Based Approach to Compliant GxP Computerized Systems, and a member of the ISPE GAMP Global Steering Committee and GAMP Editorial Board. Wyn is a GAMP, Data Integrity, and Part 11 trainer and course developer for ISPE, and is technical consultant to ISPE. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science 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. He received the ISPE UK Fellow Award in 2010.