CHE3502 — Risk in Life Science Industry
Distinctions of the life science industries related to the specific regulations that apply to consumer health products. Use of risk analysis techniques, including FMEA, Fault Tree and 5 Why’s, 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 lead to scientifically justified investigations supported by evidence, and the identification of effective corrective and preventative actions (CAPA). pre-req: ChE 2500