Wednesday, 15th January 2014
Starts: 15 January 2014
Mr Sion Wyn
Regulatory compliance for computer systems in the pharmaceutical industry – working with the FDA
Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field.
He assisted the FDA with its re-examination of 21 CFR Part 11, and was 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 has received the FDA Group Recognition Award for work on Part 11.
Wyn is the editor of ISPE’s 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.
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.
Redwood 2.60c (NLT)
1.30pm. Refreshments from 1:20pm
Open To: Public
Staff and Students