Complete all courses and requirements listed below unless otherwise indicated.
Required Courses
Code | Title | Hours |
---|---|---|
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 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
RGA 6234 | Risk Management: Compliance and Processes | 4 |
RGA 6275 | Product Development and Process Validation | 2 |
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