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.
*Curricular information is subject to change
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
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 |