Frank Behnisch
Formerly CSL Behring
Referent:innen
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Zielgruppe
This 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 training:
- You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP® 5)
- 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 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 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.
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.
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
Workshop: 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
Workshop: 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
Interactive Discussion: Specifying Requirements - URS vs. FS
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
Workshop: Test Incidents
Change and Configuration Management During the Project Phase
- Regulatory requirements
- Configuration management
- Change management
- Responsibilities
- Recommendation
- When to start?
- Areas of concern
Workshop: 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
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
Tel. +34 (93) 503 53 00
sants@barcelo.com
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.
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.
The official conference language will be English.
Fees (per delegate, plus VAT)
ECA Members € 2,290
APIC Members € 2,390
Non-ECA Members € 2,490
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
Social Event
On Wednesday evening, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation - Introduction on Risk Management" on 21 April 2026. Book both courses directly as a combination here.
ECA Members € 2,290
APIC Members € 2,390
Non-ECA Members € 2,490
EU GMP Inspectorates € 1,245
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
Social Event
On Wednesday evening, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation - Introduction on Risk Management" on 21 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.
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.
Contact
Questions regarding content:
Dr Andreas Mangel, +49 (0) 62 21 84 44 41, mangel@concept-heidelberg.de.
Questions regarding content:
Dr Andreas Mangel, +49 (0) 62 21 84 44 41, mangel@concept-heidelberg.de.
Questions regarding Organisation:
Ms Manuela Luckhaupt, +49 (0) 62 21 84 44 66, luckhaupt@concept-heidelberg.de
Ms Manuela Luckhaupt, +49 (0) 62 21 84 44 66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 22 April 2026, 09.00 – 17.30 h
Thu, 23 April 2026, 08.30 – 17.30 h
Fri, 24 April 2026, 08.30 – 16.00 h
All times mentioned are CEST.
Thu, 23 April 2026, 08.30 – 17.30 h
Fri, 24 April 2026, 08.30 – 16.00 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 2290,- |
| Non ECA Member*: | € 2490,- |
| EU/GMP Inspectorates*: | € 1245,- |
| APIC Member Discount*: | € 2390,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
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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