Dec 26, 2024  
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2021/2022 University Catalog [ARCHIVED CATALOG]

R A 778 - Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices

Units: 3

Prerequisite(s): R A 602 .

Quality and compliance functions in biotechnology and pharmaceutical companies to include out-of-specification results, developing product specifications, and writing compliant process deviations. Good Laboratory Practices (GLPs). Graded approach for Active Pharmaceutical Ingredients (APIs) manufacturing. Biologics, drugs, and medical device regulations. Quality control (QC) role vs. quality assurance (QA) role. Current trends in industry.