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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 remaining challenges and understanding how a Maturity model approach may provide a framework to enable innovation and plan future progress. Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software" on 13th September 2022, many questions and concerns have been raised regarding the impact of the guidance on 21 CFR Part 11. The session will focus on the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including leading industry experts along with representatives from the FDA. Please join us for what should be a very engaging and informative session.
10:00 - 10:15: GAMP 5 Second Edition - A Year On by Heather Watson 10:15 - 10:40: GAMP 5 Second Edition - Maximizing Value by Sion Wyn 10:40 - 11:00: GAMP 5 Second Edition and Future Guidance by Chris Clark 11:00 - 11:30: Implications and Opportunities of CSA on GAMP 5 Second Edition and 21 CFR Part 11 by Francisco Vicenty, Daniel Walter, Ken Shitamoto, Jason Spiegler, Sion Wyn, Chris Clark and Heather Watson, moderated by Khaled Moussally
Speaker(s):
Chris
Clark,
Director,
TenTenTen Consulting Limited
Khaled
Moussally,
Executive Vice President Clients & Regulatory Relations,
Compliance Group Inc