Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management – Webinar Recording/Transcript
Want to ensure your QRM will keep you compliant — and competitive — moving forward?
It’s not easy given that understanding the principles of quality risk management (QRM) and how to apply them are not well-described in the regulations, despite ICH Q9 having been adopted by the FDA in 2006.
Meanwhile, EU GMP Annex 1 Manufacture of Sterile Medicinal Products, currently in draft, may be finalized in late 2021 and will increase risk management and risk assessment to ensure contamination control.
Add to these the fact that many organizations are making or have recently made decisions about how to maintain production levels given the pandemic and this webinar is a tremendous opportunity to explore the risks and apply risk-based decisionmaking to fully understand the long-term impacts.
Amanda McFarland, a QRM and microbiology senior consultant with ValSource, Inc., will clarify the regulations relative to risk management and how to apply the principles of QRM to do just that.
- Best practices related to QRM program development and execution, including process, people and documentation
- Ways to integrate QRM into your quality systems such as change control and investigations and how integration can benefit your organization
- The PIC/S Aide-Memoire on QRM and how you can prepare for a QRM program inspection
- How to evaluate the risk management tools available to you to meet regulatory requirements, such as PHA, REM, HACCP and FMEA
- Recognize the critical QRM regulations that apply to pharma such as ICH 9, ICH Q10, ISO 14644 and Annex 1
While risk is everywhere, and ever-increasing, this webinar will enable you to use the principles of QRM and risk-based decisionmaking to ensure compliance going forward.
Meet Your Presenter
Amanda McFarland is a QRM and microbiology senior consultant with ValSource, Inc., assisting companies with the design and implementation of CGMPs, microbiology and QRM programs. She specializes in the creation and implementation of risk management programs, developing custom risk-based strategies and risk facilitation. Ms. McFarland currently serves as the Parenteral Drug Association (PDA) QRM interest group co-lead, the PDA Southeast Chapter secretary and is a faculty member of the QRM Certificate Training Series at PDA Training and Research Institute.
Who Will Benefit
- QRM program professionals
- Audit managers
- Managers and directors of QA/QC
- Directors of operations and operations personnel involved in the audit process
- Regulatory affairs managers and directors
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Aug. 5, 2021