Frank Behnisch
Formerly CSL Behring
Referierende
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Highlights
- The Use of GAMP® 5 Second Edition
- The EU GMP Guide Annex 11 Including Draft 2025
- Up to 10 Workshops / Interactive Sessions
Combination booking: We offer you a discount of 600 EUR! 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.
- The Use of GAMP® 5 Second Edition
- The EU GMP Guide Annex 11 Including Draft 2025
- Up to 10 Workshops / Interactive Sessions
Combination booking: We offer you a discount of 600 EUR! 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.
Zielgruppe
These training courses are directed at specialists and executives from
- Production
- Quality Control / Quality Assurance
- Engineering /Automation
- IT
Zielsetzung
Computerised System Validation: Introduction to Risk Management
- 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
Computerised System Validation: The GAMP® 5 Approach
- 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
Programm
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
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
Computerised System Validation: The GAMP® 5 Approach
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
Austria Trend
Parkhotel Schönbrunn
Hietzinger Hauptstr. 10-14
1030 Vienna, Austria
Phone +43 1 878 08-0
Email parkhotel.schoenbrunn@austria-trend.at
Austria Trend
Parkhotel Schönbrunn
Hietzinger Hauptstr. 10-14
1030 Vienna, Austria
Phone +43 1 878 08-0
Email parkhotel.schoenbrunn@austria-trend.at
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 2,780 EUR
APIC Members 2,980 EUR
Non-ECA Members 3,180 EUR
EU GMP Inspectorates 1,290 EUR
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
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.
ECA Members 2,780 EUR
APIC Members 2,980 EUR
Non-ECA Members 3,180 EUR
EU GMP Inspectorates 1,290 EUR
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments. VAT is reclaimable.
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.
Get Together
On Tuesday evening (27 April), 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.
On Tuesday evening (27 April), 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.
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 6221 84 44-41, mangel@concept-heidelberg.de.
Questions regarding content:
Dr Andreas Mangel, +49 6221 84 44-41, mangel@concept-heidelberg.de.
Questions regarding Organisation:
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Ms Manuela Luckhaupt, +49 6221 84 44-66, luckhaupt@concept-heidelberg.de
Datum & Uhrzeiten
Computerised System Validation:
Introduction to Risk Management
Tue, 27 April 2027, 09:00-18:00 h
(Registration and coffee: 08:30-09:00 h)
Computerised System Validation:
The GAMP® 5 Approach
Wed, 28 April 2027, 09:00-17:30 h
(Registration and coffee: 08:30-09:00 h)
Thu, 29 April 2027, 08:30-17:30 h
Fri, 30 April 2027, 08:30-16:00 h
All times mentioned are CEST.
Introduction to Risk Management
Tue, 27 April 2027, 09:00-18:00 h
(Registration and coffee: 08:30-09:00 h)
Computerised System Validation:
The GAMP® 5 Approach
Wed, 28 April 2027, 09:00-17:30 h
(Registration and coffee: 08:30-09:00 h)
Thu, 29 April 2027, 08:30-17:30 h
Fri, 30 April 2027, 08:30-16:00 h
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 2780,- |
| Non ECA Member*: | € 3180,- |
| EU/GMP Inspectorates*: | € 1290,- |
| APIC Member Discount*: | € 2980,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Aufzeichnung 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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