Quality risk management according to ICH Q9

Decision to master

Structure a risk assessment aligned with ICH Q9 and justify the selected level of control.

Learning objectives

• Explain the quality intent associated with "Quality risk".
• Identify the risks, responsibilities and evidence expected in a professional situation.
• Formulate a proportionate, traceable and defensible decision.

Indicative programme

1. ICH Q9 risk management principles and terminology
2. Risk assessment tools: FMEA, HACCP, preliminary risk analysis
3. Control level, risk review and communication
4. Application: structure a complete Q9 risk assessment

Prerequisites

• GMP fundamentals and quality system (or equivalent experience)