Computerised System Validation: Maintaining Compliance during Operation - Live Online Training
26-28 February 2025
Course No. 21144
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Note: All times mentioned are CET.
Objectives
The programme has been substantially revised for 2025, with increased focus on the periodic review and evaluation of computerised systems in operation. What evidential records need to be maintained, and how can these be efficiently leveraged to confidently demonstrate ongoing compliance to auditors and inspectors?
Four additional good reasons why you should attend:
Delegates will gain understanding of the controls needed to maintain validated systems in compliance throughout their operational lifecycle.
Taking a risk-based approach, you will learn how these controls can be scaled across a wide range of computerised systems, allowing you to focus your resources on the most critical systems and the most critical system components
You will learn the importance of role clarity and making best use of Subject Matter Experts and the Quality Unit.
In workshops / case studies / exercises, you will get the chance to put the theory into practice and discuss suitable solution strategies with your colleagues
Background
The greatest part of the system life cycle is represented by daily operation. It is now a clear regulatory requirement that GxP computerised systems must be kept in compliance throughout their operational lifetime. Audit experience shows that companies struggle with this task. Once the implementation project is complete and the computerised system is handed over for use how can the validated state be maintained? What exactly is required and how can these requirements be successfully established and maintained?
The course reflects the requirements of the EU Annex 11 and the approaches contained in the GAMP Guides (GAMP®5 2nd Edition and ‘A Risk-Based Approach to Operation of GxP Computerized Systems – A Companion Volume to GAMP®5’).
Target Group
This Education Course is directed at anyone who must deal with the validation and operation of computerised systems and the maintenance of the validated state.
Date & Technical Requirements
Date Live Online Training Wednesday, 26 February 2025, 09.00 h – 17.30 h CET Thursday, 27 February 2025, 09.00 h – 17.30 h CET Friday, 28 February 2025, 09.00 h – 13.00 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