Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international GxP regulations in this field. 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. 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 the ISPE GAMP5 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. Wyn is the lead GAMP and Part 11 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 SOPs, performing 21 CFR Part 11 assessments, and supplier audits. 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 including ERP, manufacturing execution, electronic document management, EBRS, process control and monitoring, environmental monitoring, manufacturing equipment, and laboratory systems. 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.