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Highlighting the challenges facing QA/QC in today's pharmaceutical manufacturing and control environment, this course examines what it takes to have an effective, functional QA/QC. Instruction covers the risk management decisions that the Quality Unit must make for (1) failure and Out of Specification investigations, (2) approving validation protocols and reports, (3) setting scientifically defensible specifications, (4) establishing quality agreements when outsourcing, and (5) preparing for regulatory inspections. The role of QA/QC in auditing GXPs (GMP, GLP, and GCP) will be covered.

Note: Prerequisite: "Introduction to QA/QC for Drugs and Biologics" required.

Course Number: BIOL-40021
Credit: 3.00 unit(s)