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Regulatory Authority Assessor Competency and Training Requirements

Origin/Publisher:

IMDRF

Content:
This document applies to Regulatory Authorities conducting assessments of AOs. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of AOs by ensuring that Regulatory Authority personnel have the necessary commitment, competency, experience, and training before conducting an assessment or participating in a decision to recognize an Auditing Organization.

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GMP Conferences by Topics

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