BMSC 4701 - Product Development and Validation

3 Credit Hours
Prerequisites: Prerequisites: Admission to the Quality Assurance in Life Sciences Industries Certificate and BMSC 3701 with a grade of C or higher.
Description
In this course, students will be exposed to the major design processes that are critical to life science product, process and specification development. Topics to be covered include: cradle to grave product and process development, prototype builds, scalability, design of experiments, variability, control, specification development and validation methodology. Instructors will explore how rigorous human factor engineering studies and clinical trials provide essential inputs into the product development process. The students will be introduced to concepts such as gap analysis, risk assessment, master plan, process characterization, installation qualification, operational qualification, measurement system analysis, repeatability and reproducibility (data collection / analysis), performance qualification/validation. Course cannot be repeated for credit.