Computerised System Validation: Introduction to Risk Management
6 May 2025, Vienna, Austria
Course No. 21552
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Objectives
Get to know the current risk management approaches of ICH Q9 and GAMP®5
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
Background
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.
Target Group
This 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.
Testimonials
Seminar Programme as PDF