ABT 740 - Regulatory Practices and Compliance

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 agencies and to submit required documentation for successful product development. 3 hrs lec. online per wk.

Prerequisites:
All of the following: ABT 700, ABT 705, and ABT 710

3 cr.