About this Program
Regulatory affairs specialists play a vital role in the health care landscape, bridging the legal, business and scientific aspects of developing new biomedical products. This innovative field offers growing career opportunities and the chance to help improve people’s lives.
In this three-course certificate program, you’ll learn about the roles and responsibilities of regulatory affairs professionals in the development of new medical products. We’ll explore the regulatory jurisdiction of the U.S. Food and Drug Administration. You’ll delve into the laws and regulations that apply to the design, development, testing and production of biomedical products, including biologics, drugs, biotechnology-derived therapeutics, vaccines and medical devices, including software as a medical device. We’ll also examine post-market issues and requirements.
Professionals who want to enter or advance in the biomedical regulatory affairs field, or those who want to better understand the subject.
What you'll learn
- The history of U.S. drug and medical device regulation and the jurisdictional scope of the FDA
- The role of regulatory oversight in product design, development and manufacturing, including quality control, scale-up, Good Manufacturing Practices (GMPs) and quality systems
- The FDA inspection process and regulatory procedures, with a focus on the Quality System Inspection Technique (QSIT)
- Post-market surveillance requirements, reporting and enforcement actions
Get Hands-On Experience
- Visit local companies to learn about GMPs
- Participate in group projects to gain in-depth experience in a variety of regulatory areas
Choose From Noncredit and Credit Options
By completing this certificate program, you can earn up to 9 credits toward degree requirements should you later be accepted into the Master of Science in Biomedical Regulatory Affairs. To use these credits, you must enroll in the credit version of the certificate program and obtain graduate nonmatriculated status before you register for the first course. If you don’t plan on pursuing a graduate degree, you can choose the noncredit offering. See Noncredit & Credit Options.
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