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EU GMP Annex 11 action plan: Assessment, strategy and digital solutions for compliance
Discover how to navigate the most significant EU pharmaceutical computerized systems update in over a decade, presented by Stephen Ferrell, Chief Product Officer at Valkit.ai
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About this webinar:
The proposed EU GMP Annex 11 revision represents the most significant regulatory update to pharmaceutical computerized systems in over a decade. In this webinar, Stephen Ferrell provides a critical analysis of the proposed regulations, examining key implementation challenges and comparing EU requirements with FDA 21 CFR Part 11 and ICH guidelines.
Drawing on his experience as a GAMP 5 contributing author, Stephen shares practical insights for developing strategic compliance roadmaps that balance regulatory adherence with operational efficiency during the anticipated 3-5 year industry-wide implementation timeline.
Key takeaways:
- Comprehensive regulatory analysis: Understand the shift from risk-based guidance to prescriptive technical requirements, including mandatory audit trails, and how EU standards compare with FDA 21 CFR Part 11 and ICH guidelines.
- Implementation strategies and challenges: Identify critical contradictions and compliance gaps affecting existing systems, with practical approaches for addressing these issues while maintaining operational efficiency.
- Future-ready validation programs: Discover how modern quality management platforms can address evolving regulatory demands and build validation programs that accommodate regulatory evolution while maintaining competitive advantage.
Meet our speakers
Stephen Ferrell
Chief Product Officer, Valkit.aiStephen Ferrell is Chief Product Officer at Valkit.ai, a leading provider of validation and compliance solutions for the pharmaceutical industry. With over 25 years of experience in pharmaceutical quality systems and computerized system validation, Stephen has helped hundreds of companies navigate complex regulatory requirements while implementing innovative technology solutions. He was a contributing author to ISPE GAMP 5 2nd edition, as well as a number of other ISPE guides and industry publications.
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