Stay updated on the recent revisions to ICH Q9R1 Quality Risk Management by regulators and gain insights into its practical application in pharmaceutical manufacturing.
This training is crucial to understand the revisions made in response to regulatory observations of inadequacies in quality risk management processes, which have shown unjustified assumptions, unsystematic approaches, inadequate formality relative to risk, subjective evaluations, and potential impacts on product availability
Participants will be brought up-to-date with the latest requirements of Q9R1, understanding its changes and their implications for pharmaceutical products and processes across various situations and product types.
Engaging with experts in the field provides an ideal platform to grasp these recent updates comprehensively and discuss their practical implications.
Benefits of attending
- Keep up to date with the changes
- Understand the implications on products and processes
- Discuss new terms such as subjectivity, uncertainty, importance and complexity
- Stay abreast of the latest thinking on Quality Risk Management (QRM)
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Course Content
- Background to Q9(R1) regulatory update- Summary of the main steps for a QRM approach from 'Initiation to Review'
- Explanation of the main changes and how this will impact development and manufacturing processes
- Introduction of new terms such as formality, risk-based decision-making, subjectivity, and what they mean
- Examples of good and poor practices in the use of QRM for a range of pharmaceuticals
- The importance of QRM and product availability risks
- How risk may change across the product lifecycle with examples
