Dr Robert Stephenson
Rob Stephenson Consultancy
Referent:innen
Yves Samson
Kereon
Stefan Münch
Körber Pharma Consulting
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.
Zielsetzung
- 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
Hintergrund
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
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
Zielgruppe
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.
Date / Venue / Presentations / Certificate
Date
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)
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
Introduction – What the Participants expect
Leveraging Suppliers Expertise: An Overview of Good Practice
Performing a Supplier Assessment
Supplier Audit – The Supplier’s View
Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
Leveraging Supplier Testing
Workshops
- Workshop 1: Selecting a Supplier
- Workshop 2: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
| ECA-Member*: | € 1090,- |
| Non ECA Member*: | € 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"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Für Lieferanten: Ausstellungs- und Sponsoringmöglichkeiten
Seminarprogramm als PDF
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