In this webinar, the concepts associated with Quality Risk Management as outlined in ICH Q9 Guidance and the importance of the Risk Priority Number (RPN) are discussed. This knowledge will then be applied to decision making in prioritizing and defining the extent of qualification necessary based on the concepts advanced in the FDA’s Guidance on Process Validation of January 2011.
I. ICH Q9 and Quality Risk Management and The Risk Priority Number (RPN)
• Understand what risk is and the concepts of risk management
• What are the most risky operations in the Pharmaceutical industry
• How to define risk levels and risk level factors
• Discuss the concept of “mitigating efforts being commensurate with the level of risk.”
II. FDA’s view of the Importance of Risk Management in GMP Compliance and Validation
• August 2002 FDA Initiative on Risk Based Compliance for the 21st Century
• FDA’s Process Validation Guidance and Risk Management
III. Apply Risk Management to the Validation Process
• Apply Risk management techniques to prioritizing the qualification effort.
• Qualification of facility and utilities
• Qualification of processing equipment
• Qualification of high risk sub systems
• Process Performance Qualification (PPQ)