Data Integrity applied to USP in cGMPs

Practical application of electronic and handwritten data integrity to ensure cGMP compliance in the USP context.

MODULE

Available in French, English

about 2 hours of content

Ref. P2M5

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Goals

In summary

Prerequisites

Scientific background, initial experience in bioindustries, chemistry, pharmacy.

Course modules
about 2 hours

Data Integrity applied to USP in cGMPs

This activity helps to understand why data integrity is essential in USP, to master the ALCOA+ principles, and to explore a structured method for investigating and resolving deviations.

This activity presents several use cases to identify data integrity breaches and apply an investigation and CAPA model to a real-life situation.

This activity enables participants to identify the benefits and risks associated with data digitalization, navigate the requirements of 21 CFR Part 11, and recognize non-compliant behaviors to verify that electronic data meets integrity expectations.

Available in French, English

about 2 hours of content

Ref. P2M5

Request details

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