Regulatory Affairs and Quality Assurance Graduate Program at Temple University School of Pharmacy
Post-Master's Certificate in
Biopharmaceutical Manufacturing and Regulatory Affairs (Pharmaceutical Biotechnology)
Brochure on the Post-Master's Certificate in Biopharmaceutical Manufacturing and Regulatory Affairs (Pharmaceutical Biotechnology)
- Graduates of our MS in RAQA degree are welcome to complete the Post-Master’s Certificate in Biopharmaceutical Manufacturing and Regulatory Affairs.
- Four courses beyond the MS are required to receive this Certificate. One of the courses must be Pharmaceutical Biotechnology (8005). If this course was already completed as part of the MS, the student may substitute another course from the list of accepted courses below.
- Courses taken for the completion of the MS degree will not be counted.
- Students must apply for the Certificate before taking any courses: Application.
Only the following courses may be taken towards completion of the program:
- Biotechnology: Bioprocess Basics (5471)*
- Production of Sterile Products (5492)
- Sterilization Processes (5493)
- Development of Sterile Products (5501)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)*
- Biologics/ Biosimilars: A Regulatory Overview (5515)*
- Vaccines: RA and QA Issues (5572)
- Regulatory Bioanalysis (5621)
- Pharmaceutical Biotechnology (8005)*
*These courses must be completed as part of the certificate. If students previously took them as part of the MS in RAQA, they may select other courses on this list.
Transfer credits are not accepted towards Temple’s certificate programs. Students may receive more than one post-master's certificate.
Masterís Students from Other Accredited Schools in the U.S.
If you did not receive the MS in RAQA from Temple University, you are required to complete five approved courses to receive the Post Master's Certificate in Biopharmaceutical Manufacturing and RA. Please refer to the Brochure regarding course choices.
You must have sufficient industry experience and demonstrated familiarity with basic tenets of RAQA to pursue the Temple U Post Master's Certificate in Biopharmaceutical Manufacturing and RA.
You must apply before starting the program: Application.
Please include a letter of request to the Assistant Dean of RAQA, indicating which courses you intend to pursue and citing your industry experience.
Also include a copy of your resume and a photocopy of your final transcript from the school where you received your doctoral or master's degree.
Send all application materials to:
Temple University RAQA Graduate Program
Attn: Assistant Dean
425 Commerce Drive, Ste 175
Fort Washington, PA 19034
Formal permission to pursue the Post-Master's Certificate in Biopharmaceutical Manufacturing and RA must be received from the Assistant Dean before the student starts any courses in the Advanced Certificate program.
How to Obtain the Certificate when all courses have been completed:
Submit the Notice of Completion to the RAQA Office (hard copy only) 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.