Computer Validation: Introduction to Risk Management

Computer Validation: Introduction to Risk Management

Copenhagen, Denmark

Course No 17254



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Frank Behnisch, CSL Behring GmbH
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy


  • You get to know the current risk management approaches of ICH Q9 and 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, 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.

Target Group

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 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.

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