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ABT 760

QUALITY AND PROJECT MANAGEMENT

3 credits.

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

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