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. In a world of innovative technology, it is critical that the students gain an understanding of computer system and software validation to ensure the quality of data generation, data storage, and digital processes used in manufacturing and products with digital components using technical and practical aspects expected in the regulated life science industries. While the course content, developed by Pathway for Patient Health, will be provided online, regular meetings with the instructor are expected.