This introductory course highlights the challenges facing QA/QC in today’s pharmaceutical manufacturing and control environment. Instruction covers the importance and underlying principles of QA/QC and best practices for developing a cost-effective, risk-managed QA/QC strategy for products through different phases of clinical development and into commercialization. Students will also explore the risk management decisions of the Quality Unit for non-conformities and deviation issues for biologic/biopharmaceutical products, and when managing customer complaints, out of expectations investigations, and recalls.
Course Number: BIOL-40354
Credit: 3.00 unit(s)
Related Certificate Programs: Quality Assurance and Control