Dr Robert Stephenson
Rob Stephenson Consultancy
Referent:innen
Yves Samson
Kereon
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation Master Class". Book both courses directly as a combination here.
Zielgruppe
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.
Zielsetzung
- 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.
Background
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.
Programm
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
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 € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 645
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments VAT is reclaimable.
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 € 1,090
APIC Members € 1,190
Non-ECA Members € 1,290
EU GMP Inspectorates € 645
The conference fee is payable in advance after receipt of invoice and includes conference documentation, lunch and all refreshments VAT is reclaimable.
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
Tue, 19 May 2026, 09.00 - 17.30 h
All times mentioned are CEST.
All times mentioned are CEST.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
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"
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E-Mail: info@concept-heidelberg.de
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