Computer Validation: Introduction to Risk Management
You can find all other dates of this seminar in this overview.
Speakers
Frank Behnisch, CSL Behring GmbH, Germany
Dr David Selby, Selby Hope International, UK
Dr Robert Stephenson, Rob Stephenson Consultancy, UK
Objectives
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
Background
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.
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.
Programme
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
- 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
- The GAMP methodology for risk management
- Where to apply risk management in validation
- Methods of assessing risk
- What is risk ranking
- How is it carried out
- How is it documented?
- A few useful applications
- What are the criteria to use to select a supplier?
- Why does supplier selection matter?
- How should the selection process be conducted?
- 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
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?
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.
Workshop 4: Assessing and Selecting a supplier
- What factors influence supplier assessment?
- What risks are associated with supplier selection?
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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