Computerised System Validation: Introduction to Risk Management
If you book this course together with the course "Computerised System Validation - The GAMP® 5 Approach", we will offer you a discount of € 600,-
21 April 2026, Barcelona, Spain
Course No. 22308
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Target Group
This Training is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computerised system validation.
Objectives
Get to know the current risk management approaches of ICH Q9 (R1) and GAMP®5 Second Edition
Become familiar with the use of the latest methods and tools for risk analysis when validating computerised systems
Learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
In 3 workshops you can see how these procedures are applicable
Background
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9 (R1), GAMP® 5 Second Edition, ASTM E2500-25) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how their principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice- oriented guidance in performing this task.
Programme
Introduction – What Do You Want from this Day?
Capturing delegates expectations
Sharing and reducing to key points in groups
Sharing with all delegates and tutors
An Introduction to Risk Management (including ICH Q9)
Definition of “Quality Risk Management”
Principles of Quality Risk Management
Application of the principles in validation
Methods of assessing and controlling risk
Regulatory expectations for risk management
Risk Management the GAMP® 5 Way
The importance of Risk-based Decision Making
How the GAMP® 5 Risk Management Approach aligns with ICH Q9
The 5-Steps you will need to follow described in detail
Risk Management throughout the System Lifecycle
Short workshop on Risk Identification and Risk Analysis
Risk Assessment the GAMP® 5 Way
The simple GAMP® 5 Risk Assessment Method
Assessment Scales for computerised systems that work
Functional Risk Assessments and Risk Reduction Strategies
Using risk to determine Test Rigour
Workshop: Risk Management Applied to a Computerised System
High Level and System Risk Assessment
Evaluating identified risks
Controls to mitigate unacceptable risks
Workshop: Functional Risk Assessment Applied to a Control System
How to document a FRA
Classification of risks into H, M, L
What are the conclusions from the risk assessment?
What options do you have to mitigate (reduce) the higher risks?
Using the output to determine verification Tasks?
An Introduction to Risk Ranking
What is risk ranking?
How is it carried out?
How is it documented?
A few useful applications
Workshop: Applying Risk Ranking to Determine System Remediation Priorities
How is severity determined?
How can scales be created?
Ranking the risks
Developing a risk-based action plan
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona, Spain Tel. +34 (93) 503 53 00 sants@barcelo.com
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 € 1,090 APIC Members € 1,190 Non-ECA Members € 1,290 EU GMP Inspectorates € 695 The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation - The GAMP® 5 Approach " on 22-24 April 2026. Book both courses directly as a combination here.
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
