Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate

The Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate in Temple University’s School of Pharmacy provides a foundation in the regulations that govern development and production in the biotechnology industry. Offered part-time through the School of Pharmacy’s Regulatory Affairs and Quality Assurance (RAQA) graduate program, this 12-credit-hour graduate certificate is designed to fit your professional schedule, with classes offered at Temple’s Fort Washington campus. In addition, it can be completed pre- or post-master’s, with the option to apply credits toward the Master of Science in Regulatory Affairs and Quality Assurance. 

With a focus on real-world biopharmaceutical regulations, this certificate is ideal for those with a bachelor’s degree in biochemistry, biology, chemistry, physics or a health-related discipline, or those who currently work in related industries. The Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate can help you advance your existing career or create new professional opportunities. 

The curriculum reviews the compliance standards that ensure the quality and safety of modern biotechnology products, from their development in labs to their introduction in the marketplace. Learn the state and federal agency regulations for products such as cancer vaccines, insulin and other therapeutic drugs. Coursework focuses on 

  • the pharmaceutical science behind the discovery of biotechnology products, including biologics, biosimilars and biopharmaceuticals;
  • the processes used to sterilize biotechnology products, including regulatory requirements for thermal, gaseous, radiation, filtration and aseptic processing;
  • the requirements for sourcing and testing the materials used in the production of biotechnology products; and
  • the technologies and unique considerations associated with the manufacturing and distribution of biotechnology products.

Classes & 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 in-person at Temple’s Fort Washington campus, which is only 20 miles from Temple’s Main Campus. You’ll have three years to take the four required courses and one elective. The required courses are

  • Biologics/Biosimilars: A Regulatory Overview,
  • Biotechnology: Bioprocess Basics,
  • Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics and
  • Pharmaceutical Biotechnology.

Students who have completed the MS in RAQA are eligible for the Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate. Students who are earning the post-master’s certificate and who took any of the required courses during the completion of the RAQA MS can replace some of the required courses with others. 

Students in the pre-master’s certificate program may be able to count their credits toward the RAQA MS.

Learn more about the Biopharmaceutical Manufacturing and Regulatory Affairs Graduate Certificate curriculum.

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Tuition & Fees

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

Tuition rates 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.

These tuition costs apply to the 2018–2019 academic year.

Pennsylvania resident: $1,072.00 per credit
Out-of-state: $1,358.00 per credit

Learn more about our tuition and fees.

PH-BMRA-GRAD

Additional Program Information