Computerised System Validation Master Class

4-6 June 2025, Copenhagen, Denmark

Course No. 21562

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Speakers

Frank Behnisch

Frank Behnisch

CSL Behring

Yves Samson

Yves Samson

Kereon

Dr Robert Stephenson

Dr Robert Stephenson

Rob Stephenson Consultancy

We offer you a discount of € 600 if you book this training course together with the course "Leveraging Suppliers".Book both courses directly as a combination here.

Objectives

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

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

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

Date
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
 
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
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.

Programme

Computerised System Validation Master Class

Seminar Programme as PDF

Introduction – Gain Understanding of Delegate Experience and Background
 
Project Life Cycle
 
Presentation of the Project Mandate
 
URS (User Requirement Specification): Structure and Content
 
Introduction to Qualification Planning
 
Qualification / Validation Plan: Structure and Content
 
Introduction to Functional Specifications
 
Risk Management Refresh: Scalability and Objectives
 
Migration and supporting Activities
 
Introduction to Design Review
 
Practical Approach to Design Review
 
Source Code Review
 
Testing and Verification: Objectives and Content
 
Alternative & Agile Approaches
 
Integration Project vs bespoke Development
 
Qualification / Validation Report: Objectives and Content
 
Legacy Systems
 
System Classification
 
Today / Future IT Compliance Challenges
 
 
Workshops
  • Workshop 1: What the Delegates expect
  • Workshop 2: Elaborating URS
  • Workshop 3: Elaborating URS
  • Workshop 4: Elaborating a Qualification / Validation Plan
  • Workshop 5: Elaborating Functional Specifications
  • Workshop 6: Performing Functional Risk Assessment
  • Workshop 7: Design Review Plan
  • Workshop 8: Elaborating OQ / FT Test Cases
  • Workshop 9: Elaborating a Qualification / Validation Report

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This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

ECA-Member*: € 2290,-
Non ECA Member*: € 2490,-
EU/GMP Inspectorates*: € 1245,-
APIC Member Discount*: € 2390,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Further dates on-site
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Further dates online
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Recording
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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