The Graduate Certificate in Quality Assurance Compliance prepares you to navigate the compliance aspects of industry-specific regulatory standards throughout the product lifecycle.  

Through a targeted curriculum, you will build a deep working knowledge of fundamental regulatory compliance and be able to differentiate between the distinct stages of the regulatory and standards-based compliance processes.  

As a graduate, you will be able to demonstrate proficiency in the application of compliance-associated regulations and standards – while maintaining the level of safety and efficacy upon which products were approved for marketing by FDA and other global regulatory agencies. 

Program objectives 

• 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 

• 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 

Unique Features 

1. Choose from elective courses that cover a broad range of practical and relevant issues in the field 
2. The BTC 4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals and other external pharmaceutical industry partners 
3. Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs