Quality Assurance in Biomedical Product Regulation, Graduate Certificate

Global regulatory requirements and compliance standards for development, marketing approval, and clinical utilization of new biomedical products continue to evolve rapidly in today’s dynamic healthcare environment. The professional practice of quality assurance involves ensuring compliance to appropriate industry-specific regulatory standards throughout a biomedical product’s life cycle. Completion of the Graduate Certificate in Quality Assurance in Biomedical Products Regulation provides students the opportunity to:

  • Describe the general standards utilized by the U.S. Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of existing and new biomedical products utilized by healthcare practitioners in the U.S. market
  • Demonstrate proficiency in the application of compliance-associated regulations and standards for global biomedical products throughout their life cycle
  • Differentiate between the distinct stages of the global biomedical product commercialization process from regulatory and standards-based compliance perspectives
  • Detail the fundamental regulatory compliance and standards-based processes under which biomedical products must be manufactured in order to maintain the level of safety and efficacy upon which they were approved for marketing by FDA and other global regulatory agencies

Students that successfully complete this certificate may apply their courses toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices.

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

RGA 6000Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation2
RGA 6001Introduction to Food and Drug Administration Medical Device Regulation2
RGA 6002Regulatory Compliance Culture2
RGA 6275Product Development and Process Validation2
Electives
Complete a minimum of 8 quarter hours from the following:8
Human Experimentation: Methodological Issues Fundamentals
Validation and Auditing of Clinical Trial Information
Application of Quality System Regulation in Medical Device Design and Manufacturing
Drug and Device Supplier Risk Management: Compliance and Processes
Regulatory Compliance in the Pharmaceutical Industry: A Collaborative Approach

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required