About the Certificate
The post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) specialists to receive formal recognition for studying the highly specialized, rapidly growing field of pharmaceutical biotechnology, which includes the manufacturing techniques and applicable regulations used in the development and production of biotechnology products. The first biopharmaceutical product, namely, recombinant human insulin, was approved in 1982. Since then, products derived through biotechnology have provided advances in medicine 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. This certificate delves into the complex regulations governing the development, manufacturing and distribution of such products.
Through completion of the certificate, students understand the following:
- the pharmaceutical science behind the discovery of biotechnology products, including biologics, biosimilars and biopharmaceuticals;
- the requirements for sourcing and testing materials used in the production of biotechnology products;
- the technologies and unique considerations associated with the manufacturing and distribution of biotechnology products;
- the applicable regulations involved with biotechnology products; and
- the processes used to sterilize biotechnology products, including regulatory requirements for thermal, gaseous, radiation, filtration and aseptic processing.
Time Limit for Certificate Completion: 3 years
Campus Location: Online and Fort Washington
Full-Time/Part-Time Status: The post-master's certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.
Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.
Admission Requirements and Deadlines
Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.
APPLY HERE to the post-master's certificate program.
Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field.
Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline.
Certificate Requirements
Number of Credits Required to Complete the Certificate: 15
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Core Courses | ||
| QARA 5471 | Biotechnology: Bioprocess Basics | 3 |
| QARA 5475 | 3 | |
| QARA 5515 | Biologics/Biosimilars: A Regulatory Overview | 3 |
| QARA 5577 | Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics | 3 |
| Elective | 3 | |
| Select one from the following: | ||
| Production of Sterile Parenterals | ||
| Sterilization Processes | ||
QARA 5501 | Development of Sterile Products | |
| Microbiological Concepts in Pharmaceutical Manufacturing | ||
| Vaccines: Regulatory Affairs and Quality Assurance Issues | ||
| Total Credit Hours | 15 | |
GPA Required to be Awarded the Certificate: 3.0 minimum
Contacts
Certificate Program Web Address:
Department Information:
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728
267-468-8560
Mailing Address for Application Materials:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728