Temple University 3 credits QARA
This course provides an introduction to cGMP (current good manufacturing practices). Regulations for drugs under the Food, Drug and Cosmetic Act (21 CFR 210 and 211) and their implication for personnel, buildings, equipment, and records will be thoroughly reviewed and studied. It includes a study of pertinent legal decisions and regulatory actions based on non-compliance. Note: This course fulfills the GxP requirement for RA and QA MS students and for the Drug Development Certificate. Students with extensive manufacturing experience in GMPs may petition the School to allow them to replace the basic GMP class with Advanced GMPs. To do so, students must have at least five years of GMP experience and submit a resume to the RA and QA Office for final approval.
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