Concurrent Session: **NEW** GAMP 5 Second Edition Roundtable
Date
October 31, 2022
Concurrent Session: **NEW** GAMP 5 Second Edition Roundtable | 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.
Speakers
Program Manager, Case for Quality, FDA/CDRH
Interim President and CEO, ISPE
Senior Executive Consultant, Q-FINITY Quality Management
Global Head of Quality and Compliance, Citadel Health
Partner, ProductLife Group
Vice President, Corporate Quality, Syneos Health
Guy Wingate, PhD
Independent Consultant, Glaxosmithkline PLC (Retired)
Director, TenTenTen Consulting Limited
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In 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…
**NEW** GAMP 5 Second Edition Roundtable
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…
