Computerised System Validation - Introduction to Risk Management and the GAMP 5 Approach - Live Online Training
Learn How to Plan, Implement and Document Effectively Computer Validation Activities
25-28 November 2025
Course No. 21651
Note: All times mentioned are CET.
Combination booking: Save € 600,- by booking both courses! You can also book an individual course separately. Book "Computerised System Validation: Introduction to Risk Management" here. Book "Computerised System Validation - The GAMP® 5 Approach" here
Target Group
Computerised System Validation: Introduction to Risk Management
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 computer validation.
Computerised System Validation: The GAMP® 5 Approach
This Live Online Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.
Objectives
Computerised System Validation: Introduction to Risk Management
Why you should attend this Live Online Training:
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
Computerised System Validation: The GAMP® 5 Approach
Why you should attend this Live Online Training?
You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
In case studies / workshops / interactive sessions you can see how the theoretical foundations will apply practicable
Background
Computerised System Validation: Introduction to Risk Management
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.
Computerised System Validation: The GAMP® 5 Approach
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the Training will be the current requirements for the validation of computerised systems like GAMP® and their GxPoriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
Programme
Computerised System Validation: Introduction to Risk Management
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
Computerised System Validation: The GAMP® 5 Approach
Introduction – What the Participants Expect An open session capturing the expectations of the delegates
Validation Overview
What do we mean by Validation?
Validation and Qualification
Organising and Planning
Good Documentation Practice
Specification & Verification
System Inventory
System Description
Computerised Systems in Practice
Definition of a Computerised System
Scope of CSV (Computerised System Validation)
Laboratory Equipment
Automation / Process Control
Facility Management
GxP Applications – GCP / GLP / GMP / GDP / GVP
IT / OT Infrastructure
Regulatory Framework Overview
GxP: Regulated Good Practices
EudraLex
Relevant Regulatory Framework for CSV Purposes
US GxP Regulations
Industry Standards
EU Annex 11 “Computerised Systems”
General principles
Project phase
Operation
ERES requirements
Annex 11 vs 21 CFR Part 11
How can you implement it?
About Annex 11 draft (2025)
GAMP® 5 Software Categories
System Structure
Software Categories 1, 3, 4, 5
End User Application
User View vs IT Perspective
Case Study: Software Categorisation According to GAMP® 5
The GAMP® 5 Second Edition: A Risk-Based Approach to Compliant GxP Computerised Systems
Applicability
GAMP® 5 Key Principles
Life Cycle / ASTM E2500-25 / V-Model
Guide Structure
Risk Management according to ICH Q9
Data Integrity Considerations for CSV
What data are relevant?
ALCOA+: Data Integrity criteria
Paper vs hybrid vs electronic systems
Data integrity requirements for CSV projects
Validation Planning
CSV: A Life cycle approach embedded into the QMS
Validation Master Plan
Qualification & Validation on Project / System Level
Qualification / Validation Plan
Supplier Assessment / Supplier Management
Risk Management
Documentation
Verification
Supporting Processes / System Release
Case Study: Validation Planning
Specifying Requirements
Importance of Requirements Specification (RS)
RS Scope and Contents
Roles & Responsibilities
Requirements Good Practices
POLDAT
Functional Specifications – Building the Bridge
Importance of URS – FS linking
FS Scope and Contents
Roles & Responsibilities
FS and FRA
FS Good Practices
Workshop: Self Evaluation of Compliance with Regulatory Expectations
Design Specification
CS – Configuration Specification
Detailed Specification
SDS – Software Design Specification
SMS – Software Module Specification
HDS – Hardware Design Specification
NDS – Network Design Specification
Requirement Traceability / Design Review
Regulatory expectation vs Good Engineering Practice
Vertical Traceability / Horizontal Traceability
How to trace? - Embedded Traceability / Traceability Matrix
Testing of GxP Systems
Verification vs Validation Terminology
Software testing
Acceptance testing / Factory acceptance test (FAT) / Site acceptance test (SAT)
Change and Configuration Management During the Project Phase
Regulatory requirements
Configuration management
Change management
Responsibilities
Recommendation
When to start?
Areas of concern
Interactive Session: Change Management
Validation Reporting and Handover to Operation
Linking the Validation Plan and Validation Report
Key documents
Validation summary reports
Handover to Operation
CSV: Presentation to Inspectors
Managing the inspection
What inspectors want to see
Warning Letters and 483s
Inspection experiences
Lessons to learn
CSV – Specific Aspects: Automation
System Overview / Specifications
GAMP®5 and risk analysis
Findings & consequences
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 € 2,780 APIC Members € 2,980 Non-ECA Members € 3,180 EU GMP Inspectorates € 1,590 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.
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
Introduction to Risk Management Tue, 25 Nov 2025, 09.00 – 18.00 h
GAMP 5 Approach Wed, 26 Nov 2025, 09.00 – 17.30 h Thu, 27 Nov 2025, 09.00 – 17.30 h Fri, 28 Nov 2025, 09.00 – 16.00 h
All times mentioned are CET.
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