The Center for Professional Advancement, New Brunswick, NJ
August 6-8, 2007
Who Should Attend:
This is an ideal introductory/refresher course. Flexibility gives response to more profound inquiries. It will benefit domestic, multinational and/or foreign enterprises.Positions: QA/QC, Auditors, Investigators, Trainers, Analysts, Operators, Engineers, Supervisors, Directors, Research Industries: Pharmaceutical, Legal, Biological, Biogeneric, Health Care, Dietary Supplement, Academia, Consultant, Regulatory, Biopharmaceutical, Combination Product Manufacture e.g., Medical Device
Description:
This course will introduce you to Current Good Manufacturing Practice (cGMP) in the pharmaceutical and allied industries. Topics covered will include not only the legal requirements for cGMP in the Federal Food, Drug, and Cosmetic Act but, primarily, the practical how-to of purchasing, manufacturing, packaging, labeling and QA/QC, as well as training production personnel in cGMP. The faculty consists of individuals with long and distinguished experience in the field. Throughout this course, the fundamentals of FDA inspections commonly surface. There is special emphasis on discussing procedures and practices of this regulatory agency to help firms comprehend management aspects of FDA inspections.
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