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Presentation on ICH Q9

Presentation on ICH Q9

ICH AssessmentI

Q9 Basic Risk Management Facilitation Methods

Q9 Combination of Tools

Q9 Development

Q9 Executive Summary

CH Quality Risk Management Key Messages

Q9 Facilities Equipement utilities

Q9 Failure Mode Effects (Criticality) Analysis (FMEA & FMECA)

Q9 Fault Tree Analysis (FTA)

Q9 Hazard Analysis and Critical Control Points (HACCP)

Q9 Hazard Operability Analysis (HAZOP)

Q9 Integrated Quality Management

Q9 Materials Management

Q9 Packaging Labelling

Q9 Preliminary Hazard Analysis (PHA)

Q9 Production

Q9 Risk Ranking and FilteringICH Control Strategy Key Messages Q9 Supporting Statistical Tools

Q9 Applications overall notes



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