Introduction – What do you want from this day?
- Capturing delegates expectations
- Sharing and reducing to key points in groups
- Sharing with all delegates and tutors
An Introduction to Risk Management (including ICH Q9)
- Definition of “Quality Risk Management”
- Principles of Quality Risk Management
- Application of the principles in validation
- Methods of assessing and controlling risk
- Regulatory expectations for risk management
Risk Management the GAMP 5 Way
- The importance of Risk-based Decision Making
- How the GAMP 5 Risk Management Approach aligns with ICH Q9
- The 5-Steps you will need to follow described in detail
- Risk Management throughout the System Lifecycle
- Short workshop on Risk Identification and Risk Analysis
Risk Assessment the GAMP 5 Way
- The simple GAMP®5 Risk Assessment Method
- Assessment Scales for computerised systems that work
- Functional Risk Assessments and Risk Reduction Strategies
- Using risk to determine Test Rigour
An Introduction to Risk Ranking
- What is risk ranking
- How is it carried out
- How is it documented?
- A few useful applications
Workshop 1: Risk Assessment in Validation
Risk management applied to a computer system
- Evaluating identified risks
- Classification of risks into H, M, L
- Controls to mitigate unacceptable risks
- Links to the validation plan and protocols
In this workshop, delegates will use the GAMP methodology. The participants will work on a case study in which the risks associated with a computer system are assessed and managed to reduce the testing workload in validation.
Workshop 2: Risk Management in Validation
Risk management applied to a control system
- What are the conclusions from the risk assessment?
- What options do you have to mitigate (reduce) the higher risks?
- How will the output affect the protocol?
Based on a real case study, delegates will use the same risk assessment techniques to determine where to focus the qualification of a packaging line.
Workshop 3: Applying Risk Ranking to determine periodic review priorities
- How is severity determined?
- How can scales be created?
- Ranking the risks
- Developing a risk-based action plan.
Delegates will apply the techniques of risk ranking to determine which systems present the highest risk to the patient and should therefore be reviewed first.