Computerised System Validation: Leveraging Suppliers
3 June 2025, Copenhagen, Denmark
Course No. 21560
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Stefan Münch
Körber Pharma Consulting
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation Master Class". Book both courses directly as a combination here.
Objectives
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
Background
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
Target Group
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.
Date / Venue / Presentations / Certificate
Date Tuesday, 3 June 2025, 09.00 h – 18.00 h (Registration and coffee 08.30 h - 09.00 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