Biopharmaceutical Manufacturing and Regulatory Affairs Certificate (Pre-Master's) (RAQA)

Biopharmaceutical Manufacturing and Regulatory Affairs Certificate (Pre-Master's)

(Pharmaceutical Biotechnology)

The first biopharmaceutical product (recombinant human insulin) was approved in 1982. Since then, products derived through pharmaceutical biotechnology have provided medical advances that include therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors. The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous, and highly complicated. The Pharmaceutical Manufacturing and RA Certificate delves into the complex regulations governing the development, manufacturing, and distribution of such products.

Required courses:

  • Pharmaceutical Biotechnology (8005)
  • Biotechnology: Bioprocess Basics (5471)
  • CMCs - Biologics (5577)
  • Biologics/Biosimilars: A Regulatory Overview (5515)

One elective from:

  • Production of Sterile Products (5492)
  • Sterilization Processes (5493)
  • Development of Sterile Products (5501)
  • Microbiological Concepts in Pharmaceutical Manufacturing (5512)
  • Vaccines: RA and QA Issues (5572)
  • Regulatory Bioanalysis (5621)

Transfer credits are not accepted towards Temple‚Äôs certificate programs. 

Brochure - Pharmaceutical Manufacturing and RA 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.

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.