Cost Effective and Convenient - in your office or conference room
Implementing Risk Management in the
Validation Process - ICH Q9
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
January 24, 2014
In this seminar we will discuss the concepts associated with Quality Risk Management as outlined in the ICH Q9 Guidance and learn to develop a Risk Priority Number (RPN) for real life situations. 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 issued in January 2011.
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
- How to apply RPN to prioritize risk mitigation and the concept of “mitigating efforts being commensurate with the level of risk.”
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
Applying risk management to the validation process
- Applying 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)
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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|Get the Audio recording and presentation file
GMP140124E - audio recording and handout materials
Implementing Risk Management in the Validation Process
Gamal Amer, Ph.D.
Gamal Amer, Ph. D. is Principal at Premier Compliance Services, Inc.; Management Consultants for compliance and manufacturing operations performance in the life sciences industry. He holds a Ph. D. in Chemical Engineering and has over two decades experience in the Pharmaceutical and related industries. He has held positions of increased responsibility with leading pharmaceutical, consumer product and engineering consulting firms over the years. His experience includes comprehensive process design in bulk pharmaceutical 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 consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers. He has lectured extensively in the US, Europe, Asia and the Middle East, taught many courses, and authored many papers which were published in peer reviewed publication. He is a member of ISPE, PDA, ACS and AIChE.
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