Biotechnology Quality & Regulatory Compliance Graduate Certificate (Online)

Course Offerings

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The BQRC certificate consists of three to four semesters with online instruction and ongoing faculty contact through online platforms. Complete the 12 required credit hours in just 18-22 months while balancing your professional and personal commitments.

Required Courses:

  • Drug Development: A review of drug discovery and drug development, with emphasis on the regulatory aspects of these activities. Animal preclinical research and human clinical research are discussed in detail. In addition, the process for the assembly of an IND and NDA is discussed along with the Phases (I,II,III) of human clinical trials. The CMC (chemistry manufacturing and control) aspects of drug development are presented along with ICH documents and manufacturing process analytical technologies. The course concludes with a brief review of international regulatory issues and patents. (3 credits)
  • Good Regulatory Practices: Includes a review of the FDA and ICH regulations on good manufacturing, good laboratory, and good clinical practices. The meaning of these regulations, the globalization of practices, and the roles and responsibilities of various professionals implementing these regulations are addressed. Special emphasis will be detailed coverage of the process for the assembly and submission of an IND or NDA, and the function of the regulatory affairs department in a pharmaceutical company. (3 credits)
  • Molecular Basis of Manufacturing: This graduate course is aimed at professionals in the fields of pharmaceutical manufacturing, pharmaceutical development, pharmaceutical analysis, clinical supplies and regulatory. The course will also benefit persons interested in intellectual property and patents. The course is fast-paced but assumes no prior knowledge of pharmaceutical manufacturing. (3 credits)
  • Quality Management, Audits and Inspections: Advanced topics in quality management and business improvement methods that apply to the pharmaceutical industry. Emphasis is placed on specific issues of industry audits and inspections, as well as successful selection and presentation of business and quality improvement projects. (3 credits)