Computerised System Validation: GMP Compliant Documentation
Participants receive templates / sample documents from various validation phases
15-17 September 2026, Copenhagen, Denmark
Course No. 22398
Speakers
Uwe Mai
Bayer
Yves Samson
Kereon
Dr Rainer Gnibl
GMP Inspector
Target Group
IT
Quality Assurance
Production / Quality Control
Engineering – Automation - Technology
System Suppliers and Service Providers
Objectives
Which Documents for the Validation of Computer-based Systems are Required by Regulations?
Which Documents are Checked in the Course of an Inspection?
What Level of Detail must Documents Have and Who is Responsible for Review and Approval?
GMP-relevant computerised systems must be validated. The validation activities shall be sufficiently documented. “What is not documented has not been done!” The accurate documentation of all CSV activities is the prerequisite for successfully passing regulatory inspections as well as customer audits. On the other hand, creating the documents and maintaining their integrity is also time-consuming and costly. Here it is important to find a balance between "as few as possible but as much as necessary".
This ECA training course will give an overview of the necessary qualification and validation documentation, including its structure and level of detail. The responsibilities of both suppliers as well as their regulated customers will be considered.
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Conference language The official conference language will be English.
Fees (per delegate, plus VAT) ECA Members € 2,290 APIC Members € 2,390 Non-ECA Members € 2,490 EU GMP Inspectorates € 1,245 The conference fee is payable in advance after receipt of invoice and includes conference documentation, social event including dinner on the first day, lunch on each day and all refreshments. VAT is reclaimable.
Get Together On 15 September, you are cordially invited to a get together. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Presentations/Certificate 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.
Testimonials
