Computerised System Validation - Leveraging Suppliers + Computerised System Validation Master Class
3-6 June 2025, Copenhagen, Denmark
Course No. 21561
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Stefan Münch
Körber Pharma Consulting
Frank Behnisch
CSL Behring
Objectives
Leveraging Suppliers:
Learn what activities and deliverables you should expect to see from your IS/IT supplier to demonstrate Supplier Good Practice
Learn how to verify your supplier’s capabilities so that there are “no surprises”.
Learn how to plan validation (verification) activities, leveraging the expertise of your supplier
Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system life cycle
Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship
Computerised Systems Validation Master Class:
As a specialist for the validation of computerised systems, the event will provide you with
Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
Real-life examples of how validation effort can be scaled according to risk-based approaches
Answers to specific questions, e.g. on source code review or on creating specification documents
The opportunity to bring questions from your own practice up for discussion
Background
Leveraging Suppliers: Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.
The EU-GMP Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.
This course aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve
Computerised System Validation Master Class:
The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP®5 2nd Edition, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.
Target Group
Leveraging Suppliers:
This ECA Training Course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/ IT, who have to assess, manage or work with computerised system or service providers.
The training course will also be of value to representatives from suppliers that are working or seeking to work with Regulated Companies in the Life Sciences Sector.
Computerised System Validation Master Class:
The Master Class is directed at employees from
IT
Production
Engineering
Quality Assurance
Quality Control
Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.
Date / Venue / Presentations / Certificate
Computerised System Validation: Leveraging Suppliers Tuesday, 3 June 2025, 09.00 h – 18.00 h (Registration and coffee 08.30 h - 09.00 h)
Computerised System Validation Master Class Wednesday, 4 June 2025, 09.00 h – 17.30 h (Registration and coffee 08.30 h - 09.00 h) Thursday, 5 June 2025, 08.30 h – 17.30 h Friday, 6 June 2025, 08.30 h – 16.00 h
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF