Frank Behnisch
CSL Behring
Referent:innen
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Stefan Münch
Körber Pharma Consulting
Combination booking: Save € 600,- by booking both courses! You can also book an individual course separately. Book "Computerised System Validation: Leveraging Suppliers" here. Book "Computerised System Validation Master Class" here.
Zielsetzung
Leveraging Suppliers:
- Learn what activities and deliverables you should expect to see from your IS/IT supplier to demonstrate Supplier Good Practice
- Learn how to verify your supplier’s capabilities so that there are “no surprises”.
- Learn how to plan validation (verification) activities, leveraging the expertise of your supplier
- Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system life cycle
- Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship
Computerised Systems Validation Master Class:
As a specialist for the validation of computerised systems, the event will provide you with
- Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
- Real-life examples of how validation effort can be scaled according to risk-based approaches
- Answers to specific questions, e.g. on source code review or on creating specification documents
- The opportunity to bring questions from your own practice up for discussion
Hintergrund
Leveraging Suppliers:
Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.
The EU-GMP Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.
This course aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve
Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.
The EU-GMP Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.
This course aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve
Computerised System Validation Master Class:
The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP®5 2nd Edition, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.
Zielgruppe
Leveraging Suppliers:
This ECA Training Course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/ IT, who have to assess, manage or work with computerised system or service providers.
This ECA Training Course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/ IT, who have to assess, manage or work with computerised system or service providers.
The training course will also be of value to representatives from suppliers that are working or seeking to work with Regulated Companies in the Life Sciences Sector.
Computerised System Validation Master Class:
The Master Class is directed at employees from
- IT
- Production
- Engineering
- Quality Assurance
- Quality Control
Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.
Date / Venue / Presentations / Certificate
Computerised System Validation: Leveraging Suppliers
Tuesday, 3 June 2025, 09.00 h – 18.00 h
(Registration and coffee 08.30 h - 09.00 h)
Tuesday, 3 June 2025, 09.00 h – 18.00 h
(Registration and coffee 08.30 h - 09.00 h)
Computerised System Validation Master Class
Wednesday, 4 June 2025, 09.00 h – 17.30 h
(Registration and coffee 08.30 h - 09.00 h)
Thursday, 5 June 2025, 08.30 h – 17.30 h
Friday, 6 June 2025, 08.30 h – 16.00 h
Wednesday, 4 June 2025, 09.00 h – 17.30 h
(Registration and coffee 08.30 h - 09.00 h)
Thursday, 5 June 2025, 08.30 h – 17.30 h
Friday, 6 June 2025, 08.30 h – 16.00 h
Radisson Blu Scandinavia Hotel
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
Amager Boulevard 70
2300 Copenhagen S, Denmark
Phone: +45 3396 50 00
Email guest.copenhagen@radissonblu.com
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.
After the event, you will automatically receive your certificate of participation.
After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Programme Leveraging Suppliers - 3 June 2025
Introduction – What the Participants expect
- An open session capturing the expectations of the delegates
Leveraging Suppliers Expertise: An Overview of Good Practice
- What is current Good Practice?
- Optimising Supplier involvement
- Integrating the Supplier’s expertise and deliverables into your validation process
- How to do more with less
Performing a Supplier Assessment
- Why Assess the Supplier?
- The Overall Process
- Assessment Topics
- Types of Assessment
- Corrective Actions & Follow Up Audits
Workshop: Selecting a Supplier
- What factors to consider?
- How to focus the assessment?
- How to engage with the supplier?
- How to report and manage the findings?
- Regulatory expectations
Supplier Audit – The Supplier’s View
- Defining the role of the supplier
- What must the supplier do?
- What must the regulated company do?
Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
- Quality Management System
- Establishing Requirements
- Producing Specifications
- Testing and Release
- Support and Maintenance
Workshop: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
Leveraging Supplier Testing
- Test script development
- Test script execution
- Test script review and approval
Programme Computerised System Validation Master Class - 4-6 June 2025
Introduction – Gain Understanding of Delegate Experience and Background
Workshop 1: What the Delegates expect
- Capturing delegates expectations
- Sharing and reducing to key points
- Facilitated discussion
Project Life Cycle
- Life cycle refresh
- Life cycle activities and deliverable by Agile approaches
Interactive Session: Good Validation Practices
- IT and System Governance
- CSV roles and responsibilities
- Role of Quality Unit
Presentation of the Project Mandate
- Presentation of the case study application
- Project Mandate
Workshop 2: Elaborating URS
- Outlining and drafting URS for the case study application
- Debriefing and plenum discussion
URS (User Requirement Specification): Structure and Content
- URS: Purpose and objectives; Roles & responsibilities
- URS structure
- Prioritizing user requirements
- URS: how much is enough?
Workshop 3: Elaborating URS
- Elaboration of a consolidated URS draft for the case study application
- Debriefing
Introduction to Qualification Planning
- Qualification Planning refresh
- Q-Plan Purpose and objectives
- Roles & responsibilities
- Topics to be covered
Workshop 4: Elaborating a Qualifcation / Validation Plan
- Filling out a High Level and System Risk Assessment for the case study application
- Outlining & drafting a Qualification Plan for the case study application
- Debriefing
Qualification / Validation Plan: Structure and Content
- Q-Plan structure
- Q-Plan scalability
- Qualification/Validation strategy
Introduction to Functional Specifications
- FS refresh
- Purpose and objectives
- Roles & responsibilities
- Recommendation regarding the elaboration of FS
Workshop 5: Elaborating Functional Specifications
- Outlining FS for the case study application
- Drafting some functionalities
- Debriefing
Risk Management Refresh: Scalability and Objectives
- Risk management refresh: purpose and objectives; process; roles & responsibilities; scalability
- Risk Management traps to avoid
Workshop 6: Performing Functional Risk Assessment
- Performing a functional risk assessment for functionalities of the case study application
- Debriefing
Migration and supporting Activities
- Risk mitigation measures: Purpose and objectives; roles & responsibilities; scheduling and scalability; risk mitigation: more than testing
- Supporting activities: What supporting processes
Introduction to Design Review
- Design Review: Purpose and objectives; Roles & responsibilities
- Design Review more than Design Qualification
Workshop 7: Design Review Planning
- Planning and elaborating a design review strategy for the case study application
- Debriefing
Practical Approach to Design Review
- Design review process: points to consider
- Design review scalability
- Recommendation
Source Code Review
- Source code Review: Purpose and objectives; Roles & responsibilities
- What should be reviewed; how to review document
Interactive Session: Good Validation Practices
- IT and System Governance
- CSV roles and responsibilities
- Role of Quality Unit
Testing and Verification: Objectives and Content
- Testing and verification: Purpose and objectives; roles & responsibilities
- Efficient Testing
Workshop 8: Elaborating OQ / FT Test Cases
- Outlining OQ/FT and PQ/FT for the case study application
- Drafting some functional test cases
- Drafting some performance test cases
- Debriefing
Alternative & Agile Approaches
- Alternative software development models
- Unified Process, Scrum
- Agility objectives
- Needs for flexible engineering methodologies
- Practical approaches and recommendations
Integration Project vs bespoke Development
- Roles & responsibilities, life cycle for: Integration projects; development projects
- What to leverage and how to leverage?
Workshop 9: Elaborating a Qualification / Validation Report
- Outlining & drafting a Qualification Report for the case study application
- Debriefing
Qualification / Validation Report: Objectives and Content
- Qualification/Validation report:
- Purpose and objectives
- Roles & responsibilities
- Report structure
- Recommendation
Bringing Legacy Systems into Compliance
- Objectives
- What shall be done?
- Recommendation
System Classification – A record-based Approach
- Needs for a system classification
- Classification criteria
- How-to classify a Systems?
Today / Future IT Compliance Challenges
- Open Source Software validation
- Challenge demands Infrastructure platforms for applications
- Global systems validation vs local defence
- Paperless recipe-based production – ISA 95 / S 88
- Cloud Computing – Data Integrity
- Validating Artificial Intelligence (AI)
- Challenges for data integrity on Lab-Systems
| ECA-Member*: | € 2780,- |
| Non ECA Member*: | € 3180,- |
| EU/GMP Inspectorates*: | € 1280,- |
| 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
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
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E-Mail: info@concept-heidelberg.de
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