Graduate Certificate: Biopharmaceutical Manufacturing and Regulatory Affairs

SCHOOL OF PHARMACY

About the Certificate

The graduate and post-master's certificate in Biopharmaceutical Manufacturing and Regulatory Affairs is intended to enable Regulatory Affairs and Quality Assurance (RAQA) students 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, whether post-baccalaureate or post-master's, 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: Fort Washington

Full-Time/Part-Time Status: The 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.

Master's Degree in Discipline/Related Discipline: Applicants completing the certificate program to earn a post-master's certificate must hold a master's degree in a Pharmacy-related field.

Bachelor's Degree in Discipline/Related Discipline: Applicants completing the certificate program to earn a post-baccalaureate certificate must hold a B.S. degree in Biochemistry, Biology, Chemistry, Physics, or a health-related discipline.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 15

Required Courses:

Core Courses
QARA 5471Biotechnology: Bioprocess Basics3
QARA 5475Pharmaceutical Biotechnology3
QARA 5515Biologics/Biosimilars: A Regulatory Overview3
QARA 5577Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics3
Elective3
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 Hours15

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://www.temple.edu/pharmacy_qara/certificates.htm

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

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

Department Contacts:

Admissions:

Wendy Lebing, MALD, M.S.

Program Coordinator

qara@temple.edu

267-468-8560