Risk and Failure Analysis

Catalog description

This course will dive into the nuances of the life science industries related to the specific regulations that apply to consumer health products. Importantly, it is desired that students take this course while on internship at a life science company such that they can experience a failure while learning all that is required for acceptable resolution. Through the use of historical risk analysis techniques, such as FMEA, Fault Tree, and 5 Why’s, students will be able to analyze a holistic set of data (in-production, across product lines, across equipment, human variability, on-market, on-stability, validation studies, change control, etc.) that will lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA).