Seminar Nr. 9061
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Frank Behnisch, CSL Behring GmbH, Germany
Dr David Selby, Selby Hope International, UK
Dr Robert Stephenson, Rob Stephenson Consultancy, UK
You get to know the current risk management approaches of ICH Q9 and the GAMP®5
You become familiar with the latest methods and tools for risk analysis and can assess their relevance to practice in the validation of computerised systems
You learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
In 4 workshops you can apply the procedures and discuss them
The current GMP regulations and guidelines (ICH Q9, GAMP®5, draft EU GMP Guide Annex 11 „Computerised Systems“) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how its principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.
This Education Course is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computer validation.
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 open session capturing the expectations of the delegates. Working in groups delegates derive their requirements from the training event and share them with the 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
An introduction to the principles and terminology used in ICH Q9, Quality Risk Management. The principles will then be applied to the validation life cycle. The regulatory expectations for risk management will be discussed.
Risk Management the GAMP® 5 Way
The GAMP methodology for risk management
Where to apply risk management in validation
Methods of assessing risk
The GAMP® 5 approach to science-based quality risk management is described for delegates to see how important effective risk management is to successful CSV. Scalability of risk identification and risk controls based on system complexity and business process analysis is also discussed.
An Introduction to Risk Ranking
What is risk ranking
How is it carried out
How is it documented?
A few useful applications
This presentation presents the principles of risk ranking and shows how it may be used in a number of applications relating to the compliance of computer systems.
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?
Delegates will understand the value of identifying a good supplier, the importance of having a good supplier selection procedure and what to look for when selecting the most appropriate supplier for your project.
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.