The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.
Kate Coleman
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Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.
Articles by Kate Coleman
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The ICH Q9 Revision and a Renewed Focus on Quality Risk Management FundamentalsPublished: December 2nd 2023 | Updated:
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