Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality and meet regulatory requirements.
This fundamental course* introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
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 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.
Wyn 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.