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Jun 01, 2024
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BARB 225 - Product Development and Validation
3 Credit(s)
Major design processes that are critical to life science product, process and specification development are explored in this course. Topics covered include: product and process development, design of experiments, variability, control, and validation methodology. Participants learn how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The participants are introduced to concepts such as gap analysis, risk assessment, process characterization, equipment qualification, measurement system analysis, repeatability and reproducibility, and performance qualification/validation.
Course Frequency: AN
Grading Method: Student option.
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