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MTQ 632. Manufacturing Process Development and Validation

Credits: 3
Department: Regulatory Affairs
Description: Quality tools to validate that a manufacturing process is well characterized, tested, capable, and controlled to demonstrate compliance and control risks and costs. Using designed experiments. Determining sample size and protocal, report writing, and validation.
Semester Offered: DEMAND
Grading Method: ABCDF

Student Learning Outcomes

1. Define a manufacturing process
2. Assess process risk (PFMEA) & its impact on product performance & design
3. Design experimentation to characterize and optimize a manufacturing process
4. Determine the appropriate sample size for experimentation, qualification, validation, and on-going process control and monitoring
5. Evaluate how to determine and influence process capability
6. Write a compliant protocol and report and a master validation plan and report
7. Define and apply process and software validation principles of Installation, Operational, Performance, and Product Performance Qualification (IQ, OQ, PQ, and PPQ)
8. Determine revalidation requirements

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