Computerised System Validation: Auditing and Leveraging IT/OT Suppliers and Service Providers
If you book this course together with the course "Computerised System Validation Master Class", we will offer you a discount of € 600,-
19 May 2026, Vienna, Austria
Course No. 22282
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.
Target Group
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.
Objectives
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.
Programme
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
Further Information
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.
Testimonials
