Risk Failure Analysis

Catalog description

Although risk and failure analysis is currently taught at many universities, this course will dive into the nuances of the life science industries related to the specific regulations that apply to consumer health products. 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 date (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).