Computer Validation: Introduction to Risk Management - Im Auftrag der ECA Academy

Programm

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 GAMP methodology for risk management
• Where to apply risk management in validation
• Methods of assessing risk

An Introduction to Risk Ranking

• What is risk ranking
• How is it carried out
• How is it documented?
• A few useful applications

Assessing and Selecting a Supplier

• What are the criteria to use to select a supplier?
• Why does supplier selection matter?
• How should the selection process be conducted?

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.

Workshop 4: Assessing and Selecting a supplier

• What factors influence supplier assessment?
• What risks are associated with supplier selection?

Delegates will assess supplier selection information to choose between two possible suppliers for an application.