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Using Risk to Guide Implementation of Quality System Elements

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Using Risk to Guide Implementation of Quality System Elements

  • Instructor: Gamal Amer, Ph. D.

  • Duration: 60 Min

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Risk is always present in every human endeavor. Managing risk to the quality of pharmaceutical products which translates to risk to the patient is the main concern of cGMP. The presentation will discuss the concept of risk levels and then identify quality system elements as identified by ICH 10 and how these are used to manage and mitigate the risk to the quality of the products.

We will discuss:

  • Quality System Elements and the risk mitigation processes
  • Implementation of process and product risk mitigation through the quality system elements Implementation of process and product risk mitigation through the quality system elements
  • How process performance and product quality improvement are achieved by implementing the Quality System Elements.

Gamal Amer, Ph. D.

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.

Education:

Ph.D. BioChemical Engineering, Virginia Polytechnic Institute & State University
M.S. Chemical Engineering, Virginia Polytechnic Institute & State University
B.Sc. Chemical Engineering, Cairo University

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