Regulatory Affairs
Issued by
University of Colorado Denver
After completing this training, the individual is capable of navigating FDA databases, interpreting guidance documents and consensus standards, and applying regulatory requirements to medical product development. They can classify products by risk, recommend appropriate regulatory pathways, and prepare elements of a regulatory submission. Equipped with practical knowledge of U.S. and global frameworks, they are prepared to contribute to regulatory strategy and compliance in industry.
- Type Certification
- Level Foundational
- Time Months
- Cost Paid
Skills
Certification Criteria
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Complete online, asynchronous modules. Engage in interactive case studies and database navigation exercises. Develop testing plans using FDA guidance documents and consensus standards. Analyze current FDA enforcement or approval news and present implications for product development. Demonstrate ability to classify the product, select the regulatory pathway, and justify testing strategies. Prepare and submit a mock regulatory submission package for a selected product type.