ICH Q9 elements of risk management Risk Identification -> Risk Assessment ->Risk Mitigation -> Risk Communication How to identify risk •Theoretical analysis-Science, engineering, or math•Based on experiments-Structured or unstructured experiments-Edge of failure or validation•Statistically derived-Trend analysis FMEA and HACCP   FMEA salient features •How can the process fail?-Power outage stops mixing-Wrong valve open sends product Read more about Risk Management for Bio-Pharma ICH Q8 and ICH Q9[…]