Frank Behnisch, CSL Behring
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy
- Get to know the current risk management approaches of ICH Q9 and GAMP® 5 2nd Edition
- Become familiar with the use of the latest methods and tools for risk analysis when validating computerised systems
- Learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
- In 3 workshops you can see how these procedures are applicable
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9, GAMP® 5 2nd Edition, ASTM E2500-20) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how their 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 Live Online Training 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 computerised system validation.
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information
you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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 / Workshop: Risk Management Applied to a Computerised System
- High Level and System Risk Assessment
- Evaluating identified risks
- Controls to mitigate unacceptable risks
Case Study / Workshop: Functional Risk Assessment Applied to a Control System
- How to document a FRA
- Classification of risks into H, M, L
- What are the conclusions from the risk assessment?
- What options do you have to mitigate (reduce) the higher risks?
- Using the output to determine verification Tasks?
An Introduction to Risk Ranking
- What is risk ranking?
- How is it carried out?
- How is it documented?
- A few useful applications
Case Study / Workshop: Applying Risk Ranking to Determine System Remediation Priorities
- How is severity determined?
- How can scales be created?
- Ranking the risks
- Developing a risk-based action plan