Yves Samson
Kereon
Referent:innen
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
Formerly CSL Behring
Combination booking: We offer you a discount of € 600! You can also book an individual course separately. Book "Computerised System Validation: Auditing and Leveraging IT/OT Suppliers and Service Providers" here. Book "Computerised System Validation Master Class" here.
Zielgruppe
Auditing and Leveraging IT/OT Suppliers and Service Providers:
This ECA training is directed at employees from Production, Quality Control/Quality Assurance, Engineering, and IT, who have to assess, manage, or work with, computerised system or service providers. This training will also be of value to representatives from supplier organisations that are working, or seeking to work, with regulated companies in the Life Sciences Sector.
This ECA training is directed at employees from Production, Quality Control/Quality Assurance, Engineering, and IT, who have to assess, manage, or work with, computerised system or service providers. This training will also be of value to representatives from supplier organisations 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.
Zielsetzung
Auditing and Leveraging IT/OT Suppliers and Service Providers:
- To help regulated organisations develop a consistent and compliant approach to the key processes of supplier selection and supplier audit/assessment in order to achieve successful outcomes throughout the complete computerised system life cycle.
- To understand the current regulatory and good practice frameworks that support these activities.
- To provide training on how to prepare, perform, and report on supplier audits and assessments.
- To share real-life case studies with the participants during two hands-on workshops.
- Learn how to use efficient leveraging to minimise duplication of effort between the supplier and the regulated Company.
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
Background
Auditing and Leveraging IT/OT Suppliers and Service Providers:
Annex 11: Computerised Systems (EU & PIC/S GMP) states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’. ‘Leveraging Supplier Involvement’ is one of the five key concepts of the ‘GAMP® 5 Second Edition Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems’.
Regulated companies are increasingly looking to their external suppliers and service providers to provide them with innovative and compliant products and services which cost-effectively fulfil their operational and business needs.
This course aims to provide attendees with the skills and knowledge to identify capable and reliable suppliers and service providers, to use supplier leveraging to improve the efficiency and effectiveness of their validation processes, and to develop long-term collaborative working relationships.
This course aims to provide attendees with the skills and knowledge to identify capable and reliable suppliers and service providers, to use supplier leveraging to improve the efficiency and effectiveness of their validation processes, and to develop long-term collaborative working relationships.
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.
Programm
Programme Auditing and Leveraging IT/OT Suppliers and Service Providers - 19 May 2026
Introduction – What the Participants expect
- Introductions and welcome
- Course objectives and topic review
- An open session capturing the expectations of the delegates
Overview of IT/OT Suppliers and Service Providers
- Suppliers and Service Providers – what is the difference?
- What should a regulated user expect from their suppliers and service providers?
- Critical success factors
- Clarifying roles and responsibilities
- Good Practice and Regulatory considerations
Supplier Selection Process
- Identification of potential suppliers/service Providers
- Creating a short-list of potential candidates
- Factors to consider when making the final selection
- Documenting the decision-making process
Workshop: Selecting a Supplier
- A workshop based on a real-life case study
Auditing IT/OT Suppliers
- Factors to consider
- Focusing the assessment
- Engaging with the supplier
- Reporting and managing the findings
- Regulatory expectations
- Corrective actions and follow-up audits
Leveraging Audit Findings
- Integrating suppliers and service providers expertise and deliverables
- Into the validation process
- Throughout the system life cycle
- Leveraging supplier testing
Workshop: Quality Planning Exercise
- Working with your supplier/service provider to develop a plan for success
Programme Computerised System Validation Master Class - 20-22 May 2026
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
Interactive Session: Good Validation Practices
- IT and System Governance
- CSV roles and responsibilities
- Role of Quality Unit
Project Life Cycle
- Life cycle refresh
- Life cycle activities and deliverable by Agile approaches
Presentation of the Project Mandate
- Presentation of the case study application
- Project Mandate
Workshop 2: Elaborating URS - Drafing 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 - Consolidated 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
Weitere Informationen
Venue
Austria Trend Hotel Savoyen
Rennweg 16
1030 Vienna, Austria
Phone +43 (1) 206330
Email savoyen@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 conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 2,780
APIC Members € 2,980
Non-ECA Members € 3,180
EU GMP Inspectorates € 1,280
The conference fee is payable in advance after receipt of invoice and includes conference documentation, 4 lunches, social event including dinner on May, 20th, and all refreshments. VAT is reclaimable.
Social Event
On Wednesday evening (20 May), 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. 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)6221 84 44 41, mangel@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 (0)6221 84 44 25, bauer@concept-heidelberg.de
Austria Trend Hotel Savoyen
Rennweg 16
1030 Vienna, Austria
Phone +43 (1) 206330
Email savoyen@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 conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 2,780
APIC Members € 2,980
Non-ECA Members € 3,180
EU GMP Inspectorates € 1,280
The conference fee is payable in advance after receipt of invoice and includes conference documentation, 4 lunches, social event including dinner on May, 20th, and all refreshments. VAT is reclaimable.
Social Event
On Wednesday evening (20 May), 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. 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)6221 84 44 41, mangel@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 (0)6221 84 44 25, bauer@concept-heidelberg.de
Datum & Uhrzeiten
Computerised System Validation: Auditing and Leveraging IT/OT Suppliers and Service Providers
Tue, 19 May 2026, 09.00 – 17.30 h
Tue, 19 May 2026, 09.00 – 17.30 h
Computerised System Validation Master Class
Wed, 20 May 2026, 09.00 – 17.30 h
Thu, 21 May 2026, 08.30 – 17.30 h
Fri, 22 May 2026, 08.30 – 16.00 h
Wed, 20 May 2026, 09.00 – 17.30 h
Thu, 21 May 2026, 08.30 – 17.30 h
Fri, 22 May 2026, 08.30 – 16.00 h
All times mentioned are CEST.
Teilnahmegebühr
| 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
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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