Sion Wyn
Conformity Ltd.

Sion is an acknowledged expert in computer system validation and compliance 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 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 the editor of ISPE's GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He is lead GAMP and Computer Systems Validation and Compliance trainer and course developer for ISPE. 

He has extensive experience in all aspects of computer systems validation and compliance, including managing validation projects, validation planning, specification and testing of systems, quality risk management, performing site and system compliance audits, performing risk assessments, writing policies and procedures, performing 21 CFR Part 11 assessments, and supplier audits. 

Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.