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 ...

(MENAFN- GlobeNewsWire - Nasdaq) Stay informed on ICH Q9R1 Quality Risk Management updates and their practical implications for pharmaceutical manufacturing. Learn the latest Q9R1 requirements, ...

ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma ...

Successful completion of this one day course provides the delegate with understanding of the principles of Quality Risk Management (QRM) and its practical application. The course is focused on ICH Q9 ...