BIOTECHNOLOGY OPERATIONS
Explore the six operational specialties of product development: Regulatory; Quality Assurance; Biomanufacturing; Quality Control; Nonclinical Development; and Clinical Development. Expand upon leadership skills by implementing biotechnology operation plans that successfully bring new products to market.
Prerequisites & course information
Requisites: Declared in Biotechnology MS Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Spring 2026 Learning Outcomes: 1. Examine key disciplines and principles required to successfully develop a variety of biotechnology products for targeted markets. Audience: Graduate 2. Select the regulatory environments required for biotechnology product development. Audience: Graduate 3. Design a biotechnology product development strategy, to clearly communicate objectives, and to provide leadership throughout implementation. Audience: Graduate 4. Appraise the interplay between quality and efficacy in biotechnology product development relative to patient, regulatory, and business risk. Audience: Graduate 5. Collaborate effectively to develop concise and accurate presentations and papers on key regulatory topics critical for biotechnology product development. Audience: Graduate Learning Outcomes: 1. Examine key disciplines and principles required to successfully develop a variety of biotechnology products for targeted markets. Audience: Graduate 2. Select the regulatory environments required for biotechnology product development. Audience: Graduate 3. Design a biotechnology product development strategy, to clearly communicate objectives, and to provide leadership throughout implementation. Audience: Graduate 4. Appraise the interplay between quality and efficacy in biotechnology product development relative to patient, regulatory, and business risk. Audience: Graduate 5. Collaborate effectively to develop concise and accurate presentations and papers on key regulatory topics critical for biotechnology product development. Audience: Graduate
Sources
- Course catalogue ↗2026-2027