cGMP for Pharmaceutical Quality Control Laboratory Personnel
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Who Should Attend
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Description
This course will provide knowledge about, and an understanding of, the U.S. Food and Drug Administration Current Good Manufacturing Practice (cGMP) regulations for drugs and finished pharmaceuticals as they relate to quality control. FDA inspections of quality control laboratories, QC responsibility for clinical trial material and the impact on the industry of “U.S. vs. Barr Laboratories, Inc.” will be covered. The course is structured to provide time for ample discussion of current real world problems encountered by the participants including the assurance of cGMP compliance acceptable to FDA, yet within the constraints of fiscal reality.