Regulatory Affairs is an excellent career for professionals who wish to work in a challenging and dynamic field that is at the center of science, business, government and most importantly, saving people’s lives.
The program provides professionals with a comprehensive and balanced education focusing on the key areas of regulatory affairs and the FDA imposed regulations pertinent to the pharmaceutical and biologics industry. This certificate covers a broad range of necessary technical and business skills, including GMP, GLP and data integirty. It is designed for professionals who want to participate in the process of drug development as regulatory professionals as well as provide a basic understanding to other experts involved directly in drug development process, including chemists, pharmacologists, and biologists.
*not including textbooks
9 -15 Months*
*Varies by student and courses taken per quarter.
Key Program Topics
Conditions for Admission
- Regulatory requirements and guidlines for the industry by FDA
- Document Management Systems
- Current trends in drug safety in the USA and the importance of Good Laboratory Practices regulations
- Application of guidance documents (ICH and FDA) to Good Manufacturing Practices
- Develop a basic Quality Management System to manage GMPs
- Implementation of data integrity standards
- Writing SOPs
To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the certificate fee.
There are five required courses in the Regulatory Affairs Essentials certificate. Students may take courses in any sequence, although taking “Regulatory Requirements for Drugs and Biologics” first is highly recommended.
There will be a $95 fee upon acceptance into the program