This course presents an in-depth coverage of the development and implementation of current good manufacturing practices (CGMPs) in the biotech industry. The course will include lectures given by experts in the topics covered and participants will engage in case studies that will provide real world exposure to the application of CGMPs in bio-manufacturing. Topics discussed include building and facilities, equipment design, utilities, process technologies, in-process controls, GMP documentation, and process validation.

Upon completion of this 16-week course students will be able to:

1. Understand the history and significance of CGMPs for the pharmaceutical and biotech industry. 2. Become knowledgeable in the CGMP regulations as established by the U.S. Food and Drug Administration. 

3. Understand the implementation of compliance with CGMP regulations from the clinical development stages through the commercial manufacture of biologics. 

4. Work on real world case studies and practice on implementing CGMPs in the workplace.