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**NEW** GAMP 5 Second Edition Roundtable

Date
October 31, 2022

In this session, the panelists will provide brief presentations on key topic areas of the GAMP 5 revision, including Critical Thinking; Applicability of iterative and incremental software development methods; IT infrastructure; Blockchain; Artificial intelligence and machine learning; and Computer Software Assurance. In addition, attendees will have the opportunity to engage in direct discussion with the primary authors of the material covering these topics.

Session Leader

Speaker Image for Chris Clark
Director, TenTenTen Consulting Limited

Speakers

Speaker Image for Frank Henrichmann
Senior Executive Consultant, QFINITY Quality Management
Speaker Image for Christopher Reid
CEO, Integrity Solutions Limited
Speaker Image for Eric Staib
Head of Quality, Validated Cloud
Speaker Image for Charlie Wakeham
Global Head of Quality and Compliance, Citadel Health
Speaker Image for Guy Wingate
Independent Consultant, Glaxosmithkline PLC (Retired)
Speaker Image for Michael Rutherford
Executive Director, Computer Systems Quality & Data Integrity, Syneos Health
Speaker Image for Francisco Vicenty
Program Manager, Case for Quality, FDA/CDRH

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