Method
Live-Online
Term
WINTER
Units
1.5 QUARTER UNITS
Cost
$750

Skills you will gain

  • FDA Communication Strategies: Develop clear, objective-driven messaging tailored to regulatory audiences.
  • Regulatory Negotiation Skills: Build persuasive communication techniques grounded in science and policy.
  • Meeting Preparation Techniques: Plan effectively for FDA meetings, inspections, and correspondence.
  • Agency Structure Knowledge: Understand the roles, mission, and divisions within the FDA.
  • Regulatory Environment Insights: Explore political, societal, and industrial factors shaping U.S. regulatory priorities.

Course Description


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.


Note(s): This course was formerly titled "Interacting with the FDA"

Professional Credit

UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours

Approved for 14 RAC recertification credits

Syllabus Library
Michelle A Carpenter
Michelle Carpenter
Feb. 24 - Mar. 24, Tuesday, 6:00pm - 9:00pm
  • Live-Online Attend via Zoom at scheduled times.
REGL.X402.(13)
Schedule
Date Start Time End Time Meeting Type Location
Tue, 02-24-2026 6:00pm 9:00pm Live-Online REMOTE
Tue, 03-03-2026 6:00pm 9:00pm Live-Online REMOTE
Tue, 03-10-2026 6:00pm 9:00pm Live-Online REMOTE
Tue, 03-17-2026 6:00pm 9:00pm Live-Online REMOTE
Tue, 03-24-2026 6:00pm 9:00pm Live-Online REMOTE
 

This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.

To see all meeting dates, click "Full Schedule" below.

You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.

This course applies to these certificate programs:

Demo