The Pharmaceutical Manufacturing: Process Development and Analysis Certificate provides a theoretical and hands-on approach to practices used in the critical stages of manufacturing, thoroughly covering key domestic regulations of GMP systems. It reflects the current culture of continuous manufacturing quality, reflecting FDA's Quality Metric Guidance document and its focus on data integrity, change control, quality risk management, and IQ, OQ, and PQ (Installation Qualifications, Operational Qualifications, and Performance Qualifications).
Students pursuing the Pharmaceutical Manufacturing: Process Development and Analysis Certificate are expected to have a strong science background, including a BS in pharmacy, chemistry, biology, or engineering from an accredited institution of higher learning. In addition, they should have a basic understanding of pharmaceutical manufacturing processes.
The Certificate consists of four courses. All of them are available entirely online.
Required courses are:
- Unit Operations (Pharmaceutics 5622)
- Process Monitoring (5629)
- Statistical Design of Experiments (DOE) (5627)
Student then select one elective from:
- Process Analytical Technology (PAT) (5625)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Risk Management for Pharmaceutical and Medical Devices (5548)
Transfer credits are not accepted towards Temple’s certificate programs. This Certificate requires participation in on-campus courses, since required trips to manuafacturing sites are included.
Brochure - Pharmaceutical Manufacturing: Process Development and Analysis Certificate
How to Receive the Certificate when you've completed the courses.
Submit the following items to the RAQA Office (hard copy only).
1. Application
2. Photocopies of your undergraduate and graduate transcripts.
3. A transcript from Temple's Banner system of courses taken in the RAQA program.
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.