Biopharmaceutical Manufacturing and Regulatory Affairs Certificate 

The Biopharmaceutical Manufacturing and Regulatory Affairs Certificate in the School of Pharmacy at Temple University 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 is part of the School of Pharmacy’s regulatory affairs (RA) and quality assurance (QA) graduate program. 

Ever since the first biopharmaceutical product (recombinant human insulin) was approved in 1982, products derived through 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. This five-course certificate presents a strong regulatory focus, enabling students to become fluent in the most current regulations and trends affecting the industry. Current pharmaceutical science methods used in the discovery of biotechnology products are studied, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacturing and distribution of biotechnology products are discussed, along with including the regulatory requirements for sterilization processes. 

The biotechnology industry continues to offer new job opportunities in the U.S. and abroad. The two largest U.S. hubs for biotechnology are Boston and San Francisco, accounting for over 50,000 jobs in pharmaceutical biotechnology discovery and development. Hundreds of small, startup biotechnology companies exist throughout the U.S. 

All courses in the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate are offered online, allowing remote students to participate in this highly relevant program. 

Post-master’s Certificate

Students have the option to complete a post-master’s curriculum in Biopharmaceutical Manufacturing and Regulatory Affairs. To apply for this 15-credit program, applicants must hold a master’s degree in a pharmacy-related field and a bachelor of science degree in biochemistry, biology, chemistry, physics or a health-related discipline.

Learn more about the Post-master’s Graduate Certificate in Biopharmaceutical Manufacturing and Regulatory Affairs.

Regulatory Affairs and Quality Assurance at the School of Pharmacy 

For over five decades, Temple University’s School of Pharmacy has provided outstanding graduate-level coursework in RA and QA. 

The School of Pharmacy  

  • pioneered RA and QA graduate education in 1968, offered the first RA and QA online degree program and offers the most comprehensive RA and QA curriculum;   

  • has outstanding expert faculty from industry and the U.S. Food and Drug Administration (FDA), assuring the latest developments and practices are taught; 

  • attracts students from the biopharmaceutical, medical device, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • schedules live courses with interactive discussions and workshops on evenings and weekends; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

Certificates provide credentials from Temple’s well-respected RA and QA graduate program, which can be applied to the RA and QA master’s degree. 

Program Format & Curriculum

The Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate is only available on a part-time basis, giving you the flexibility to take classes while working full time. Classes take place online and in-person at Temple’s Fort Washington campus, which is only 20 miles from Temple’s Main Campus.

Students will have three years to complete four required courses and one elective.

There are four required courses.

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

Students can then complete one of the following elective courses.

  • 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)

All courses must be completed from Temple University’s RA and QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. graduate school, the student may petition the RA and QA program to waive that course and take another approved elective in its place. This request must be made in writing and approved before the student pursues the certificate. 

Learn more about the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate.

See the curriculum.

Requirements 

  • Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion).  

  • Matriculated students may earn the Biopharmaceutical Manufacturing and Regulatory Affairs Certificate as they complete the MS in RA and QA.  

  • The certificate must be completed within four years. Students must apply for the certificate no more than one year after completing the course requirements. 

Learn more about the application process.

Related Graduate Degrees

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this program offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are the same, whether courses are online, on-campus, part of a certificate program or part of another master’s program at the School of Pharmacy.

Per course for Pennsylvania residents: $3,393
Per course for nonresidents: $4,218

Tuition rates at Temple University are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more.

You can view the full Cost of Attendance breakdown on the Student Financial Services website.

Accreditation

Temple University’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-BMRA-GRAD

Additional Program Information

Available online.

Visit School Site
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