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 ...
As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9. A major revision of ...
This one day course provides the delegate with understanding of the principles of and practical application of Quality Risk Management (QRM). The course is focused on ICH Q9 (QRM) requirements and its ...
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