Use cases: test your knowledge in an inspection situation!

Case studies illustrating the contribution bioproduction personnel to the implementation of data integrity and ALCOA+ principles, through various inspection scenarios.

MODULE

Available in French, English

about 2 hours of content

Ref. P6M4

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Goals

In summary

Prerequisites

Scientific or Quality Assurance (QA) educational background, with initial experience in bioindustries, chemistry, pharmaceuticals, or QA.

Basic knowledge of data integrity; otherwise, completion of the following courses is required:
-Introduction to Data Integrity. (P6M1)
-Data Integrity: How to contribute to its implementation? (P6M2)

Course modules
about 2 hours

Use cases: test your knowledge in an inspection situation!

This activity introduces the fundamentals of a regulatory inspection in the pharmaceutical industry, outlining its purpose, stakeholders, observation types, and related consequences.It continues with three real-life scenarios focused on data integrity governance, form management in production areas, and training practices in packaging.

This activity presents three situations focused on data integrity requirements in the context of computerized equipment, quality control analyses, and line clearance operations.

This activity presents four regulatory inspection scenarios in various industrial contexts: logistics, research and development, clinical trials, and system validation.It enables the identification of ALCOA+ breaches and the evaluation of good practices in investigation, traceability, and staff training.

Available in French, English

about 2 hours of content

Ref. P6M4

Request details

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