Press release
Industry Thought Experts from Compliance Group Inc to Address Audience at the Upcoming 2023 ISPE Annual Meeting & Expo Conference
2023 ISPE Annual Meeting and Expo
With a commitment to advance the Life Sciences industry, Compliance Group Inc is delighted to have its experts contribute to the following event:
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)
In this session you will hear about how GAMP 5 Second Edition has impacted 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Since the release of the FDA Draft Guidance titled "Computer Software Assurance for Production and Quality System Software" on 13th September 2022, many questions and concerns have been raised regarding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The session will also focus on the implications and opportunities of CSA draft guidance and GAMP 5 Second Edition on 21 CFR Part 11 through presentations delivered by members of the GAMP Global Steering Committee and a panel discussion, including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.
Agenda:
11:00 AM - 11:30 AM PT: Implications and Opportunities of CSA on GAMP 5 Second Edition and 21 CFR Part 11
Speakers:
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.
Moderator:
Khaled Moussally, EVP - Clients & Regulatory Relations, Compliance Group
Venue:
Virtual (or) Mandalay Bay Resort, LasVegas, NV USA
About Compliance Group Inc
To learn more about Compliance Group Inc's participation at this event and Register, visit our website at https://www.complianceg.com/compliance-events/csa-gamp5-second-edition/
Compliance Group Inc,1512 Artaius Pkwy Ste 205
Compliance Group Inc is a leader in providing specialized Quality Excellence Staffing, Business Process Consulting, and Technology Solutions to regulated industries. With 200+ employees and a presence in North America, Europe and India, our mission is to create the most efficient path to Quality Excellence by expediently delivering the precise expertise, efficient processes, and cutting-edge technologies required by our customers. We enable healthy and safe products while making Quality Frictionless for our customers. CG co-leads the FDA-Industry CSA team (FICSA) and sits on the ISPE GAMP Americas Steering Committees, helping to shape numerous industry guidance documents.
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