SURVEY OF QUALITY ASSURANCE AND REGULATORY AFFAIRS IN BIOTECHNOLOGY
Success in the biotechnology industry is based on learning the language and understanding the development process utilized in bringing products to market. Focus on techniques used in the biotechnology industry to comply with the quality and regulatory requirements set forth by professional and governmental agencies in the effort to develop, manufacture, and commercialize products safely for the public.
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: Fall 2026 Learning Outcomes: 1. Recognize, foster, and apply principles of ethical and professional conduct. Audience: Graduate 2. Describe local, national, and international agencies involved in ensuring quality and safety. Audience: Graduate 3. Integrate how testing and manufacturing relies upon regulatory requirements. Audience: Graduate 4. Demonstrate effective listening, written, verbal, and nonverbal communication skills. Audience: Graduate 5. Analyze product development and project management innovations in terms of quality assurance and regulatory compliance requirements. Audience: Graduate Learning Outcomes: 1. Recognize, foster, and apply principles of ethical and professional conduct. Audience: Graduate 2. Describe local, national, and international agencies involved in ensuring quality and safety. Audience: Graduate 3. Integrate how testing and manufacturing relies upon regulatory requirements. Audience: Graduate 4. Demonstrate effective listening, written, verbal, and nonverbal communication skills. Audience: Graduate 5. Analyze product development and project management innovations in terms of quality assurance and regulatory compliance requirements. Audience: Graduate
Sources
- Course catalogue ↗2026-2027