Pharmaceutical Quality Risk Management and ICH Q9(R1): Navigating the Global Intersection of Principle and Regulation – Webinar Recording/Transcript
Product Details
The FDA has signed on to revisions made recently to ICH Q9, the international guidelines for pharmaceutical quality risk management (QRM), and other regulators are sure to follow. Focus is now on addressing product availability risks due to manufacturing quality issues, assessing the degree of risk analysis required and managing subjectivity and bias.
To stay up to date on the ever-changing principles of risk-based quality management, don’t miss this webinar with Amanda McFarland, a senior QRM and microbiology consultant with ValSource, who will explain the revisions in the recent ICH Q9(R1). While the revision offers clarity on some of the pain points of QRM, McFarland will detail how it impacts the way you execute your QRM program. This includes learning how to increase risk management and risk assessment for a contamination control strategy (CSS), as well as the concept of “formality” as it pertains to risk tool selection.
Presentation Takeaways:
- An overview of the changes in ICH Q9(R1)
- Best practices related to QRM program development and execution, including process, people and documentation
- Methods, and the benefits of, integrating QRM into your quality systems, such as change control and investigations
- How QRM can strengthen your contamination control strategy
- Prepare for an inspection of your QRM program
- Identify the risk-management tools will enable you to meet regulatory requirements
- The critical QRM regulations that apply to pharma, including ICH Q9(R1), ICH Q10, ISO 14644 and EU GMP Annex 1
Ensure your QRM program stays compliant and up to date with this webinar. Join us by registering today.
Meet Your Presenter
Amanda McFarland, a senior QRM and microbiology consultant with ValSource, specializes in the creation and implementation of risk management programs, developing custom risk-based strategies and risk facilitation. She currently serves as the Parenteral Drug Association’s (PDA) QRM interest group co-lead and QRM and aseptic processing ANSI standard co-chair, and is a faculty member of the QRM certificate training series within PDA’s Training and Research Institute.
Who Will Benefit
- Quality management professionals
- Auditors
- Audit managers
- Managers and directors of quality assurance and quality control
- Directors of operations and operations personnel involved in the audit process
- Regulatory affairs managers and directors