Why Quality Assurance for Biomedical Products?
The Graduate Certificate in Quality Assurance for Biomedical Products provides an in-depth knowledge of the global regulatory and compliance requirements for the development, marketing approval and clinical utilization of biomedical products in today’s dynamic global healthcare environment.
The Graduate Certificate in Quality Assurance for Biomedical Products prepares you to navigate the compliance aspects of industry-specific regulatory standards throughout their product lifecycle.
In this program, students will have the opportunity to achieve the following learning outcomes:
- Describe the general standards utilized by the United States 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 US 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
- Choose from elective courses that cover a broad range of practical and relevant issues in the field
- The BTC4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals, and other external pharmaceutical industry partners
- Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices
What you'll study
Complete a minimum of 8 quarter hours from the following: