Computerised System Validation: The GAMP 5 Approach - Live Online Training
26-28 November 2025
Course No. 21652
Speakers
Frank Behnisch
CSL Behring
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 - Introduction to Risk Management". Book both courses directly as a combination here.
Objectives
Why you should attend this Live Online Training:
You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
In case studies / workshops / interactive sessions you can see how the theoretical foundations will apply practicable
Background
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the Live Online Training will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
Target Group
This Live Online Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.
Date & Technical Requirements
Date of the Live Online Training Wednesday, 26 November 2025, 09.00 h – 17.30 h CET Thursday, 27 November 2025, 09.00 h – 17.30 h CET Friday, 28 November 2025, 09.00 h – 16.00 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.