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Academic Catalog 2022-2023

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  • Quality Assurance Compliance, Graduate Certificate

Quality Assurance Compliance, Graduate Certificate

2022-2023 Edition

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        • Integrative Health and Wellness, Graduate Certificate
        • Interactive Design, Graduate Certificate
        • International Biopharmaceutical Regulatory Affairs, Graduate Certificate
        • Leadership, Graduate Certificate
        • Leading and Managing Technical Projects, Graduate Certificate
        • Learning Experience Design and Technology, Graduate Certificate
        • Medical Devices Regulatory Affairs, Graduate Certificate
        • Nonclinical Biomedical Product Regulation, Graduate Certificate
        • Nonprofit Management, Graduate Certificate
        • Organizational Communication, Graduate Certificate
        • Professional Sports Administration, Graduate Certificate
        • Project Business Analysis, Graduate Certificate
        • Project Management, Graduate Certificate
        • Public and Media Relations, Graduate Certificate
        • Quality Assurance Compliance, Graduate Certificate
        • Remote Sensing, Graduate Certificate
        • Sales Management, Graduate Certificate
        • Social Media for Organizational Performance, Graduate Certificate
        • Usability, Graduate Certificate
    • College of Science
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    • Appendix
  • Course Descriptions
  • Catalog Archives
  • Overview
  • Program Requirements

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. 

Complete all courses and requirements listed below unless otherwise indicated.

Required Courses

Course List
Code Title Hours
Complete one of the following:2-3
RGA 6000
Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6001
Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RFA 6100
Introduction to Regulatory Affairs of Food and Food Industries
Complete the following courses:
RGA 6233Application of Quality System Regulation in Medical Device Design and Manufacturing4
RGA 6234Risk Management: Compliance and Processes4
RGA 6275Product Development and Process Validation2
Choose from the following to reach 16 quarter hours:3-4
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

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