The regulatory framework required for the approval of biotechnology-derived products (or biologics) is lengthy, rigorous, and highly complicated. Temple's Post Master's Certificate in Biopharmaceutical Manufacturing and Regulatory Affairs (RA) focuses on the complex regulations governing the development, manufacture, and distribution of these products, preparing students for positions in biotechnology and sharpening the skills and knowledge of those already working in this field.
This certificate presents a strong regulatory focus, enabling students to become fluent in the most current regulations and trends affecting the industry. Topics of study include but are not limited to:
- Current pharmaceutical science methods used in the discovery of biotechnology products, including materials sourcing and testing requirement
- Technologies and unique considerations associated with the manufacturing and distribution of biotechnology products
- Regulatory requirements for sterilization processes, whether thermal, gaseous, radiation, or filtration, as well as aseptic processing
Faculty are drawn from the FDA and the biotechnology industry, assuring that the latest developments and practices are taught. These are industry and regulatory veterans with years of expertise in their specialties, sharing their considerable knowledge with students through intimate classroom discussions and hands-on workshops.
Students who earned their MS in RAQA from Temple must complete four courses from the following list beyond what was completed for the MS. Students who earned their MS elsewhere must complete five courses from this list, including those that are starred:
- 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)
- CMCs - Biopharmaceuticals (5577)*
- 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 must select other courses on this list as courses taken for the completion of the MS degree will not be counted.
Application Information for RAQA Post-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Post-Master's Certificates
- Call the RAQA office at 267-468-8560 to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Post-Master's Certificates
- A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
- Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
- You must apply before starting the program on the Graduate Application Portal.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
- Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
- Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details.
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu