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
Case Study: Risk Management Applied to a Computerised System
- Evaluating identified risks
- Classification of risks into H, M, L
- Controls to mitigate unacceptable risks
- Links to the validation plan and protocols
Case Study: 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?
An Introduction to Risk Ranking
- What is risk ranking
- How is it carried out
- How is it documented?
- A few useful applications
Case Study: 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.