This course is designed to provide a broad overview of the United States regulatory system, with some European Union structure and regulation highlights. Students will gain a basic understanding of how the FDA regulates the approval of various products and how this has changed over time, as well as the necessary inputs companies must be aware of when applying for regulatory approvals in the USA. (ALS 362)
The Certificate in Regulatory Affairs is an online, part-time 6-credit program for working professionals. The certificate aims to provide participants with regulatory affairs experience for all FDA-regulated product classes (drugs, biologics, and devices).
Participants will participate online interactive courses that focus on the regulatory challenges that applied life science companies face today and be able to present requirements to industry management and regulatory site personnel, including documentation, and accepted industry practices. Topics and skills include:
Life science professionals with applied life science experience with an interest in gaining knowledge of regulatory affairs as it related to the bioscience and healthcare industries.
Format: Online
Duration: Nine Months
Time: Early Evening (PST)
Cost: $1,041 Per Credit, Degree total 6 credits $6,240
For More Information:
Tracy Kurzy
Director, Corporate Education
(909) 607-0382
[email protected]