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Certificate in Biochemical Regulatory Engineering

Taking a new biotechnology product through a lengthy and rigorous FDA approval process can be a daunting experience. But knowing the internal framework of the FDA review and marketing authorization process can be a significant advantage.

UMBC’s post baccalaureate program in biochemical regulatory engineering guides students through the ins and outs of the FDA process and explores the numerous considerations that can help ensure product approval and sustainable regulatory compliance status. Professionals from leading bioscience companies and government agency organizations participate in this post-baccalaureate certificate program. Guest lecturers also from private entities and public organizations, with direct hands-on experience on the various topics, are featured frequently in all the courses of the program.

Learning Outcomes

By the end of this program, you will be able to:

  • Understand the key steps for obtaining FDA approval of a biotechnology product
  • Achieve a working knowledge of CGMP compliance, quality control, validation, and design of GMP biotech facilities
  • Prepare key CGMP documents, such as batch records, SOPs, validation protocols
  • Develop a QC package for key classes of biotech products

Laura Simpson.  Photo by Marlayna Demond ’11 for UMBC.

“The Biochemical Regulatory Engineering Certificate was a major factor for the AstraZeneca Formulation team to hire me. This certificate is an excellent addition for anyone going into industry in a scientist role because there is collaboration with the FDA at every step of product development. I highly recommend current students take advantage of this opportunity!” – Laura Walker Simpson, CENG PhD ’19

Certificate Curriculum

This certificate requires four courses. The courses may be taken in any sequence. However, it is recommended that students take ENCH 660: Regulatory Issues in Biotechnology first.

  • BTEC/ENCH 660: Regulatory Issues in Biotechnology
  • BTEC/ENCH 662: Good Manufacturing Practices for Bioprocesses
  • BTEC/ENCH 664: Quality Control & Quality Assurance for Biotechnology Products
  • BTEC/ENCH 666: Biotechnology GMP Facility Design, Construction and Validation

For more information, https://professionalprograms.umbc.edu/biotechnology/graduate-certificates-biotechnology/#regulatory

Program Administration

Post-Baccalaureate Certificate in Biochemical Regulatory Engineering is a Professional Program offered as part of the UMBC’s Biotechnology Master’s Degree program. UMBC’s Biotechnology master’s degree is designed to provide students with the skills sought by the biotechnology industry. The curriculum offers advanced instruction in the life sciences, along with coursework in regulatory affairs, leadership, management, commercialization and legal issues inherent to a life science-oriented business.