This course will provide an introduction to the concepts and requirements for global pharmaceutical regulatory Requirements. Chemistry Manufacturing and Controls (CMC) concepts as it relates to the manufacture of pharmaceutical products will be discussed in the course. Various regulations (FDA, ICH) that govern production of Pharmaceutical products will be addressed. Biological License Application (BLA) process for biological and plasma derivatives process will be discussed. This course provides a foundational knowledge for the registration process of Biopharmaceuticals.
Celebrating 25 years of innovation! 25.kgi.edu.