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)
Ph.D., Principal, Premier Compliance Services, Inc.
Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation. He has lectured extensively in the US, Europe, Asia, and the Middle East and taught many courses on subjects such as controlled release technology, GMP trends, Validation and Change Control, and implication of GMP compliance on process and facility design in the biotechnology industry.
Ph.D. BioChemical Engineering, Virginia Polytechnic Institute & State University
M.S. Chemical Engineering, Virginia Polytechnic Institute & State University
B.Sc. Chemical Engineering, Cairo University