QUALITY AND REGULATORY COMPLIANCE IN BIOSCIENCE

Catalog description

This course provides an overview of quality and regulatory requirements in the biotechnology industry, with a focus on research, development, and manufacturing processes. Students will examine the role of the FDA, key regulations (including GMP, GLP, and the FD&C Act), and the historical development of quality systems. The course also covers ISO standards, quality management systems (QMS), team dynamics, and the development and validation of regulatory documents such as SOPs. Designed for students preparing for careers in biomanufacturing, the course emphasizes practical applications of quality and compliance principles. Formerly BIOT 276.