Regulatory Practice and Compliance

Catalog description

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development. Components: Class Prereqs/Coreqs: P: ABT 7000 , ABT 7050 and ABT 7100 Typically Offered: Based on Student Demand