Computerised System Validation: Introduction to Risk Management - Live Online Training
Tuesday, 25 November 2025 9 .00 - 18.00 h
Course No. 21650
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Note: All times mentioned are CET. We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation - The GAMP® 5 Approach". Book both courses directly as a combination here.
Objectives
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 case studies / 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 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.
Date & Technical Requirements
Date of the Live Online Training Tuesday, 25 November 2025, 09.00 h – 18.00 h CET
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events 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.
Testimonials
Seminar Programme as PDF