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A Guide To Investigating Deviations and Failures in The Pharmaceutical Industry

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A Guide To Investigating Deviations and Failures in The Pharmaceutical Industry

  • Instructor: Gamal Amer, Ph. D.

  • Duration: 60 Min

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Investigation of failure and deviation in the pharmaceutical industry is a regulatory requirement. Recording the deviations and investigating their cause is but one step to meet the regulatory requirements. Correcting the issue based on risk assessment and understanding of the science as well as ensuring that the corrective actions are implemented within the appropriate time frame is another step. Follow-up of the actions to ensure they are completed, effective and the fact that no new issues have been introduced is what completes the activities. A summary report must be developed, reviewed, and approved by the quality unit. Process monitoring, Quarterly Review of all deviation reports as well as Annual Product Reviews (APR) are the tools necessary to ensure that negative trends do not develop and that the manufacturing process remains under control.

 

By participating in this presentation, you will learn:

 

  • What the applicable regulatory requirements are?
  • What constitutes a deviation/discrepancy/failure?
  • What are the various types of deviation you may encounter?
  • How to conduct an investigation?
  • How to use risk assessment as a tool to define the appropriate corrective and preventive actions?
  • How to prepare a deviation summary report?
  • Why product reviews?

 

The Webinar will focus on understanding deviations, how to address them and what to do about them. Specifically, we will review

 

  • 21 CFR part 211 requirements regarding deviations and the role of the quality unit
  • Deviations and how to identify them
  • Using customer complaints and adverse event reports as signals of process/product issues
  • Risk and science-based investigation of deviations
  • Writing the summary report and storing the information with the product records
  • Utilizing the information on deviation for continuous process/product improvement

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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