Quality Assurance Compliance, 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. 

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• Concentrations and course offerings may vary by campus and/or by program modality.  Please consult with your advisor or admissions coach for the course availability each term at your campus or within your program modality. 
• Certain options within the program may be required at certain campuses or for certain program modalities.  Please consult with your advisor or admissions coach for requirements at your campus or for your program modality. 

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Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

Course List

Code	Title	Hours
Complete one of the following:		2
RGA 6000	Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6001	Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RGA 6461	Cybersecurity and Regulation of Digital Health Technologies by the FDA
Complete the following courses:
RGA 6233	Application of Quality System Regulation in Medical Device Design and Manufacturing	4
RGA 6234	Risk Management: Compliance and Processes	4
RGA 6275	Product Development and Process Validation	2
Choose from the following to reach 16 quarter hours:		4
RGA 6221	European Union Compliance Process and Regulatory Affairs
RGA 6410	Fundamentals of CMC Regulations and Methods
RFA 6220	Food Safety and Surveillance: Concepts and Applications

Program Credit/GPA Requirements

16 total quarter hours required
Minimum 3.000 GPA required