Global regulatory requirements and compliance standards for development, marketing approval, and clinical utilization of new biomedical products continue to evolve rapidly in today’s dynamic healthcare environment. The professional practice of quality assurance involves ensuring compliance to appropriate industry-specific regulatory standards throughout a biomedical product’s life cycle.
Complete all courses and requirements listed below unless otherwise indicated.
Required Courses
| Code | Title | Hours |
|---|---|---|
| Complete one of the following: | 2-3 | |
| Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation | ||
| Introduction to Food and Drug Administration (FDA) Medical Device Regulation | ||
| Introduction to Regulatory Affairs of Food and Food Industries | ||
| 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: | 3-4 | |
| European Union Compliance Process and Regulatory Affairs | ||
| Fundamentals of CMC Regulations and Methods | ||
| Food Safety and Surveillance: Concepts and Applications | ||
Program Credit/GPA Requirements
16 total quarter hours required
Minimum 3.000 GPA required