REG 5310
Biopharmaceutical Quality Assurance and Control

This course will provide an introduction to the concepts and requirements for global pharmaceutical quality compliance. The course will address current Good manufacturing practices (cGMP); Quality considerations for Biosimilars; Stability of Biotechnology products; FDA inspection processes and other quality aspects associated with the manufacture of Biopharmaceuticals. This course provides a foundational knowledge for ensuring product quality. (ALS 417A/MEB 317A)

ENG 5100 or ENG 5160