This module provides the student with a comprehensive understanding of the application of Risk Management Principles to support a scientific and practical approach to decision-making throughout the lifecycle of a pharmaceutical product.
Indicative syllabus covered in the module and / or in its discrete elements;
- Principles of Risk Management and ICH Q8, Q9 and Q10
- Risk Management Roles and Responsibilities
- Risk Tools
- Cause and Effect Diagrams
- Fault Tree Analysis (FTA)
- Failure Mode Effects (and Criticality) Analysis (FMEA/ FMEAC)
- Preliminary Hazard Analysis (PHA)
- Hazard and Operability Analysis (HAZOP)
- Event Tree Analysis (ETA)
- Hazard Control and Critical Control Points (HACCP)
- Risk Ranking and Filtering
- Acceptable and Residual Risk
- Risk Based Approach to Validation
Human Heuristics
Quality Risk Management
Indicative syllabus covered in the module and / or in its discrete elements;Principles of Risk Management and ICH Q8, Q9 and Q10Risk Management Roles and ResponsibilitiesRisk ToolsCause and Effect DiagramsFault Tree Analysis (FTA)Failure Mode Effects (and Criticality) Analysis (FMEA/ FMEAC)Preliminary Hazard Analysis (PHA)Hazard and Operability Analysis (HAZOP)Event Tree Analysis (ETA)Hazard Control and Critical Control Points (HACCP)Risk Ranking and FilteringAcceptable and Residual RiskRisk Based Approach to ValidationHuman Heuristics
This module is delivered either :
- Lectures, case studies, workshops
or
- Blended – 8 weeks on-line distance learning material and 2/3 face-to-face workshops
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |