QUALITY CONTROL AND VALIDATION

Prerequisites & course information

Requisites: ABT 700 , 705 , and 710 Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Describe and contrast various quality systems and how Quality by Design is implemented in biotechnology Audience: Graduate 2. Appraise the current quality standards that are used in the US and abroad Audience: Graduate 3. Compare the Current Good Practices that are required in biotechnology product development (cGXPs) and assess how they are implemented Audience: Graduate 4. Describe the key aspects of CMC (Chemistry, Manufacturing, and Controls) and how they impact biotechnology product development Audience: Graduate 5. Design a biomanufacturing process including upstream and downstream processes Audience: Graduate 6. Justify the importance of validation (IQ/OQ/PQ) and risk assessment and reduction in biotechnology Audience: Graduate 7. Explain the importance of facilities, equipment, and utilities in biotechnology Audience: Graduate Learning Outcomes: 1. Describe and contrast various quality systems and how Quality by Design is implemented in biotechnology Audience: Graduate 2. Appraise the current quality standards that are used in the US and abroad Audience: Graduate 3. Compare the Current Good Practices that are required in biotechnology product development (cGXPs) and assess how they are implemented Audience: Graduate 4. Describe the key aspects of CMC (Chemistry, Manufacturing, and Controls) and how they impact biotechnology product development Audience: Graduate 5. Design a biomanufacturing process including upstream and downstream processes Audience: Graduate 6. Justify the importance of validation (IQ/OQ/PQ) and risk assessment and reduction in biotechnology Audience: Graduate 7. Explain the importance of facilities, equipment, and utilities in biotechnology Audience: Graduate