Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

Complete one of the following:2
Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
Introduction to Food and Drug Administration (FDA) Medical Device Regulation
Cybersecurity and Regulation of Digital Health Technologies by the FDA
Complete the following courses:
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6234Risk Management: Compliance and Processes4
RGA 6275Product Development and Process Validation2
Choose from the following to reach 16 quarter hours:4
European Union Compliance Process and Regulatory Affairs
Fundamentals of CMC Regulations and Methods
RFA 6220

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required