This subject focuses on the concept of Quality Assurance/Quality Control, planning and contribution of the Quality Assurance team in an organization. Topics covered include: QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; auditing theory; deviation management and CAPA; complaint-handling; and training on GLPs, GMPs and the International Quality Standards. Students gain significant hands on experience in document reviewing and SOP writing/reviewing as well as case study work in process deviation and Change Control processes. These skills were intentionally built into the program to provide students with meaningful QA skills that can be applied to their employment activities without a large training investment on behalf of the company who accepts them.