Post-Baccalaureate 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.
Simplified admission process
Four graduate courses (12 credit hours)
Evening classes offered on-campus
Frequent guest lectures by experts from the private and public sectors
Up-to-date information on regulatory compliance topics
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
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 Biotechnogy first.