Product Details
Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management
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Risk is everywhere. And growing. When you consistently apply appropriate QRM principles and tools, you’ll stay compliant. But if you’re struggling to manage the types — and severity — of risk with your Quality Risk Management (QRM) techniques, problems proliferate.
You’re probably exerting a huge effort: QRM must be applied consistently to an ever-increasing roster of drug development, manufacturing, distribution, and inspection and submissions review processes.
Not to mention that an effective risk management program requires multiple levels of management buy-in, innovative managers who are trained appropriately, a comprehensive strategic plan and consistent execution.
While many drugmakers rely on failure mode and effects analysis (FMEA) — sometimes called the “Swiss army knife” of risk management — experts say that’s not enough. The complexity of most situations requires a suite of tools to manage risk.
Amanda McFarland, a QRM and Microbiology Senior Consultant with ValSource, Inc., will assist you in exploring the risks and applying risk-based decisionmaking to ensure the long-term impacts of your company’s current decisions are fully understood.
Given that organizations have made or are currently making decisions about how to maintain production levels in light of the novel coronavirus, this is an incredible opportunity.
Also, EU GMP Annex 1 Manufacture of Sterile Medicinal Products is currently in draft and slated for finalization later this year. One of its most notable changes is the increase of risk management and risk assessment to ensure contamination control.
Ms. McFarland will address all of this, explore the regulations relative to risk management and explain how to apply QRM’s principles to achieve compliance and maintain a competitive advantage.
Presentation Takeaways:
- 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
- Explore the PIC/S Aide-Memoire on QRM and how you can prepare for an inspection of your QRM program
- The risk management tools available to you to meet regulatory requirements, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and FMEA
- Recognize the critical QRM regulations that apply to pharma such as ICH 9, ICH Q10, ISO 14644 and Annex 1
Come away with the tools you need to ensure your QRM works to keep you compliant and moving forward.
Meet Your Presenter:
Amanda McFarland is a QRM and Microbiology Senior Consultant with ValSource, Inc., where she assists 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’s (PDA’s) QRM interest group co-lead, the PDA SE chapter secretary and is a faculty member of the QRM Certificate Training Series at PDA’s Training and Research Institute.
Who Will Benefit:
- Auditors
- QA/QC Personnel
- R&D Management
- Compliance Officers
- Executive Management
- Laboratory Management
- Risk Management Specialists
- Regulatory/legislative Professionals
- Manufacturing Directors and Supervisors
- Validation Specialists, Scientists