Sion Wyn

Sion Wyn, 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.

Sion is the editor of ISPE’s GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, co-lead of the ISPE GAMP Guide - Record and Data Integrity and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee. He has extensive experience in all aspects of computer systems validation and compliance, including 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, Data Integrity assessments, and supplier audits.

Sion provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries. Sion 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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