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.
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.
Appearances
DateOctober 31, 2022Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software developmen…Session Leader
Director, TenTenTen Consulting LtdSpeakers
Director, Conformity Ltd.Arthur D. Perez, PhDRetired Director Information Governance and Management, Novartis Pharmaceuticals (retired)Guy Wingate, PhDIndependent Consultant, Glaxosmithkline PLC (Retired)
DateMay 9, 2023GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) maintains the principles and framework of the first edition and updates their application to reflect the realities of the modern world, including the increased importance of service providers, evolving approaches…Speaker
Director, Conformity Ltd.
DateMay 10, 2023Since the original publication date of GAMP 5 in 2008, the application and use of technology has advanced substantially. GAMP 5 Principles and Framework remain applicable and relevant today…Speakers
Director, TenTenTen Consulting LimitedManager, D-fine GmbHMedicines Inspector, GxP IT, Danish Medicines AgencyDirector, Conformity Ltd.Inspector RPharmD, Bezirksregierung MunsterGuy Wingate, PhDIndependent Consultant, Glaxosmithkline PLC (Retired)Executive Vice President Clients & Regulatory Relations, Compliance Group Inc
DateOctober 16, 2023In this session you will hear about how GAMP 5 Second Edition has had an impact on the pharmaceutical industry, the current FDA position on Computer Software Assurance (CSA) including how organizations are adapting to a CSA environment, the significant areas of progress and, conversely the remainin…Speakers
Executive Director, IT - Quality and Compliance, Gilead SciencesExecutive Vice President Clients & Regulatory Relations, Compliance Group IncProgram Manager, Case for Quality, FDA/CDRHDirector, TenTenTen Consulting LtdDirector, TenTenTen Consulting LimitedDirector, Conformity Ltd.Consumer Safety Officer, FDA/CDRH
