Many questions and concerns have been raised regarding the impact of the FDA Draft Guidance release on 21 CFR Part 11 titled “Computer Software Assurance for Production and Quality System Software” on 13th September 2022.
The session will focus on the implications and opportunities of CSA Draft Guidance and GAMP 5 2nd Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including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.
Here’s an interesting update for the healthcare professionals! Join with us at the 2023 ISPE Annual Meeting & Expo from October 15, 2023, to October 19, 2023, at Las Vegas, NV, USA.
Here are the details:
Topic: CSA – Opportunities for GAMP5 Second Edition and 21 CFR Part 11 on OCT 16, 2023, from 10:00 AM to 11:30 AM PT(Pacific Time).
Speakers:
🎤 Khaled Moussally: EVP Quality – Clients & Regulatory Relations, Compliance Group
🎤 Jason Spiegler: SVP of Strategy, Sales and Marketing, Compliance Group
🎤 Ken Shitamoto: Executive Director, IT Quality and Compliance
🎤 Francisco Vicenty: Program Manager, Case for Quality, FDA
🎤 Daniel Walter: Policy Analyst at FDA
🎤 Heather D. Watson: Company Director and Consultant, TenTenTen Consulting Limited
🎤 Chris Clark: Company Director and Consultant, TenTenTen Consulting Limited
🎤 Sion Wyn: Owner, Conformity Ltd.
Please join us for what should be a very engaging and informative session.