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Annex 11 Draft Revision: What’s New in Qualification & Validation
Автор: Hema Sharma
Загружено: 2025-08-27
Просмотров: 290
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This video explores the key updates in the draft revision of EU GMP Annex 11, focusing on qualification and validation requirements for computerized systems. Learn how the new guidance aligns with data integrity, risk-based approaches, and modern technologies like cloud and SaaS. We’ll break down critical expectations for system lifecycle management, documentation, and regulatory compliance. This session offers practical insights to strengthen your validation strategy. Stay ahead of evolving EU standards and ensure inspection readiness. Subscribe for more expert content on pharmaceutical compliance and validation.
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