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
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