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Tag: GAMP 5

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Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...

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