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Audits and Inspections of Quality Control Laboratory

Moderator A3P : Eric PETAT

facilitators: Philippe TIVOLLIER - TRB Chemedica & Philippe TAILLIEZ- ACM Pharma

The presenters present the current context in which audits and inspections are carried out in the internal or external control laboratories, in particular the objectives of these audits and the various reference systems used.
Workshop participants work in sub-groups on the conduct of audits of a QC laboratory.
The exercises integrate the technical and behavioral aspects of the auditor perspective and audited.
The groups will work on two areas:
- Auditors: evaluation in a limited time for compliance and risk related to the operation of a laboratory behaviors have as a specialist or generalist, themes ...
- Audited preparedness and responses, manage time to present the activities, demonstrate compliance with regulations.
Each group will restore its work to all participants in collaboration with the animators.

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