Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

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 ...

A change in terminology could emphasize patient protection. The current International Conference on Harmonization (ICH) Q9, Quality Risk Management guideline was recommended for adoption by the three ...

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 ...