Computerised System Validation: Introduction to Risk Management - Live Online Training
If you book this course together with the course "Computerised System Validation - The GAMP® 5 Approach", we will offer you a discount of € 600,-
Tuesday, 25 November 2025 9 .00 - 18.00 h
Course No. 21650
Note: All times mentioned are CET.
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation - The GAMP® 5 Approach". Book both courses directly as a combination here
Target Group
This Live Online 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.
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.
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 case studies / workshops you can see how these procedures are applicable
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
Case Study / Workshop: Risk Management Applied to a Computerised System
High Level and System Risk Assessment
Evaluating identified risks
Controls to mitigate unacceptable risks
Case Study / 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
Case Study / 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
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 1,090 APIC Members € 1,190 Non-ECA Members € 1,290 EU GMP Inspectorates € 645 The fee is payable in advance after receipt of invoice.
The conference fee is payable in advance after receipt of in voice. 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 26-28 November 2025.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Contacts: Questions regarding content: Dr Andreas Mangel (Operations Director), +49(0)62 21/84 44 41, mangel@concept-heidelberg.de Questions regarding organisation: Ms Sonja Nemec (Organisation Manager), +49(0)62 21/84 44 24, nemec@concept-heidelberg.de
Date & Time
Tue, 25 Nov 2025, 09.00 – 18.00 h
All times mentioned are CET.
This training/webinar cannot be booked. Send us your inquiry by using the following contact form.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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