TOPICS IN QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY

Prerequisites & course information

Requisites: Declared in the Capstone Certificate in Quality Assurance and Regulatory Affairs in Biotechnology Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Spring 2026 Learning Outcomes: 1. Evaluate quality systems used in product development and commercialization of medical devices. Audience: Graduate 2. Influence medical device development and project vision from quality assurance and regulatory affairs standpoints. Audience: Graduate 3. Produce quality and regulatory strategies to achieve organizational objectives of medical devices. Audience: Graduate 4. Compose effective communication with colleagues, customers, and regulatory agencies. Audience: Graduate 5. Troubleshoot design and manufacturing issues of medical device development to meet regulatory standards. Audience: Graduate 6. Monitor how diverse teams fit into organizational culture and successfully contribute towards product development. Audience: Graduate Learning Outcomes: 1. Evaluate quality systems used in product development and commercialization of medical devices. Audience: Graduate 2. Influence medical device development and project vision from quality assurance and regulatory affairs standpoints. Audience: Graduate 3. Produce quality and regulatory strategies to achieve organizational objectives of medical devices. Audience: Graduate 4. Compose effective communication with colleagues, customers, and regulatory agencies. Audience: Graduate 5. Troubleshoot design and manufacturing issues of medical device development to meet regulatory standards. Audience: Graduate 6. Monitor how diverse teams fit into organizational culture and successfully contribute towards product development. Audience: Graduate