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Risk and the Risk Mitigation Continuum:
The GMP Perspective
Conducted by Gamal Amer, Ph.D.
Principal - Premier Compliance Services, Inc.
January 25, 2013
This web seminar will review what is meant by risk and risk mitigation in drug product manufacturing. We will review what is meant by risk and how to quantify it. We will also discuss the principle of events resulting in increased risk and those which could potentially increase risk. A review of FDA initiative of August 2002 titled GMP compliance in the 21st Century and FDA’s proposed approaches to mitigate risk. These include Quality by Design (QbD) as the approach to mitigate risk before building the manufacturing operation, Process Analytical Technology (PAT) as an approach to mitigate risk during the normal operating of the manufacturing process, and finally Corrective Action and Preventive Action (CAPA) as the risk mitigating approach after a quality event occurs. These approaches together form what one would call a risk mitigation continuum and this is what this presentation will define.
Numerous real life situations from drug manufacturing life cycle and how to mitigate the risk associated with these situations will be reviewed. We will discuss risk in design and construction of the operation and the use of QbD to mitigate risk. We will then discuss process validation and its role in risk mitigation. The discussion will then review what is meant by PAT and how PAT can reduce and mitigate the risk of drug production by preventing failures and non-conformances. Finally, we will review CAPA as a risk mitigating quality system which plays an important role in mitigating risk associated with deviations and non-conformances as they occur during the manufacturing process.
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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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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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