A Risk-Based Approach to compliant GxP Computerized Systems
This webinar will tell you more about the second edition of GAMP 5, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5: Records and Data Integrity Guide, recognition of the FDA’s current work on computer software assurance (CSA), and an updated, dynamic and evolving set of Appendices.
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即将举办的网络研讨会This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance.
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即将举办的网络研讨会This webinar explains why EU market entry requires a fundamentally different approach than you might expect. We'll explore where home-market regulatory logic breaks down in Europe — with a specific focus on clinical evidence expectations, Notified Body interactions, and lifecycle obligations.
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点播网络研讨会Life sciences companies must digitalize fast while staying GxP compliant. In this joint webinar, QbD Group and delaware show how SAP technology and proven validation frameworks make rapid, compliant digital transformation possible. Participants will learn best practices for SAP implementation under GxP, how to avoid common pitfalls in validation and CSV, and gain insights into joint validation methodologies and real-world examples where innovation meets compliance.
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