Frank Behnisch
Formerly CSL Behring
Referent:innen
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Zielgruppe
This 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.
Zielsetzung
Why you should attend this 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 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 Online Training will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
The basis of the Online Training will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
Programm
Introduction – What the Participants Expect
An open session capturing the expectations of the delegates
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)
- Qualification testing
- Installation qualification (IQ) / configuration testing
- Operational qualification (OQ) / functional testing
- Performance qualification (PQ) / requirements testing
- Good Testing Practice
- Management of the test environment
- Verification of data migration activities
- Optimising the test strategy
Test Incident Management
- Test incident management overview
- What is a test incident?
- Test incident Management process
- Taking a risk-based approach
Case Study: Test Incidents
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
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding content:
Dr Andreas Mangel, +49 (0)6221 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
Recording from 26-28 November 2025
Duration: 15 h 50 minutes
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Regular Fee*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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