QUALITY AND PROJECT MANAGEMENT
Quality and project management issues and roles during different phases from RD to market. Introduction to Installation qualification, operation qualification and process qualification (PQ). Project management phases: conceptualizing, planning, executing and closing. Project schedule and time management tools and techniques. Project requirements including quality assurance.
Prerequisites & course information
Requisites: ABT 720 and 725 Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Spring 2026 Learning Outcomes: 1. Justify the importance of quality management in biotechnology. Audience: Graduate 2. Understand the IQ/OQ/PQ validation process. Audience: Graduate 3. Demonstrate the role of quality assurance in product development Audience: Graduate 4. Demonstrate the design for manufacturing, design for reliability, design for safety and design for sustainability concept Audience: Graduate 5. Practice the key components to project management Audience: Graduate 6. Understand the relationship of leadership to effective management to maximize outcomes Audience: Graduate 7. Explain the implementation of ISO and HACCP system in biotechnology organizations as well as how to conduct auditing activates to evaluate the system compliance Audience: Graduate 8. Use project management tools to support project management practices Audience: Graduate Learning Outcomes: 1. Justify the importance of quality management in biotechnology. Audience: Graduate 2. Understand the IQ/OQ/PQ validation process. Audience: Graduate 3. Demonstrate the role of quality assurance in product development Audience: Graduate 4. Demonstrate the design for manufacturing, design for reliability, design for safety and design for sustainability concept Audience: Graduate 5. Practice the key components to project management Audience: Graduate 6. Understand the relationship of leadership to effective management to maximize outcomes Audience: Graduate 7. Explain the implementation of ISO and HACCP system in biotechnology organizations as well as how to conduct auditing activates to evaluate the system compliance Audience: Graduate 8. Use project management tools to support project management practices Audience: Graduate
Sources
- Course catalogue ↗2026-2027