Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
GMPs for the 21st Century Certificate (Pre-Master's)
The Certificate in GMPs for the 21st Century provides a theoretical and hands-on approach to practices used in the critical stages of manufacturing, thoroughly covering key domestic regulations of GMP systems. Participants will enhance their scientific understanding of manufacturing processes, learn how to set standards for increasing product quality, understand how to improve plant efficiency while lowering production costs, and also meet domestic and global compliance requirements. It challenges students to combine science with the regulatory requirements now demanded of GMPs.
The required courses include:
- Regulatory Sciences: Managing the Guidelines for Quality (5575)
- Unit Operations (Pharmaceutics 5622)
- Process Analytical Technology (PAT) (5625) OR Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Statistical Design of Experiments (DOE) (5627)
- Process Monitoring (5629)
Transfer credits are not accepted towards Temple’s certificate programs.
Brochure - GMPs for the 21st Century Certificate
How to Receive the Certificate when you've completed the courses.
Submit the following items to the RAQA Office (hard copy only).
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
4. Notice of Completion
All materials must be received by the stipulated deadlines (January 15 for February issuance; May 15 for June issuance; and August 20 for September issuance). Sorry, but if you miss the deadline, you will have to wait until the next time certificates are issued. Certificates will be mailed to your home in late February, late June, or late September.
Note: Students may obtain only one certificate before completing the MS program, except for Food RA and QA.