Nov 23, 2020  
2013-2014 University Catalog 
    
2013-2014 University Catalog [ARCHIVED CATALOG]

BW 724 - Chemistry Manufacturing and Controls: Analytical and Manufacturing Processes in Pharmaceutical Development


This course is an introduction to documenting Chemistry, Manufacturing, and Controls (CMC) information that forms the quality sections of regulatory documents. These are critical for pharmaceutical manufacturing, testing, regulatory reporting, approval for marketing, and licensing of medicinal products. Course content includes discussion of the regulations that govern the industry and guidance documents that lead product development and reporting practices. 

Prerequisites & Notes
(Prerequisites: BW 701 and BW 704, or permission of the program director)

Credits: 3