Interacting with the FDA

Regulatory affairs professionals interact with the U.S. Food and Drug Administration (FDA) throughout the life cycle of a biomedical product. Lectures, case studies and roleplaying are used to explore the range of interactions that industry has with the FDA, including inspections and key meetings. Students learn how to prepare for these important events. This course highlights the structure, mission, jurisdiction and roles of the FDA, reviews centers within the agency, and the field offices, and examines key societal, political, industrial and biomedical drivers that impact policies, priorities, and the current U.S. regulatory environment.

This course benefits new and experienced regulatory professionals and anyone who interfaces with the FDA.

Prerequisites :

No prerequisites

Sections :

Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X402.(3) 2/11/2019 06:00 PM SANTA CLARA $700 Michelle A Carpenter Enroll