Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation & compliance and international GxP regulations in this field. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. He was consultant to US FDA during the re-examination of 21 CFR Part 11, and a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application and received the FDA Group Recognition Award for his work. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. Wyn has been a member of ISPE and the UK Affiliate since 1995 and the editor of the ISPE GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, in addition to a member of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. Wyn is the lead GAMP and Part 11 trainer and course developer for ISPE and has extensive experience in all aspects of computer systems validation and compliance. Wyn’s expertise as a specialized computer validation consultant covers all stages of the lifecycle approach to validation of computerized systems and most system types. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.