Sion Wyn

Conformity Ltd.
Director
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.

Related Articles

What You Need to Know About GAMP® 5 Guide, 2nd Edition
Features
What You Need to Know About GAMP® 5 Guide, 2nd Edition

ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and...

Applying GAMP® Concepts to Machine Learning
Features
Applying GAMP® Concepts to Machine Learning

This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition,...

GAMP® 5 Second Edition is Here!
iSpeak Blog
GAMP® 5 Second Edition is Here!

GAMP® 5 Second Edition is here! Since its publication, GAMP® 5 has been far and away the leading international guidance on GxP computerized systems validation and compliance, and it was time to update our guidance to...