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Every two years Concept Heidelberg organises a European GMP Conference on behalf of the European Compliance Academy (ECA), the European QP Association and the University of Heidelberg. This year, the meeting is scheduled in Heidelberg, Germany, on 19/20 May 2011. The motto of this fourth biennial GMP Conference is "Industry meets Authority - Authority meets Industry". To meet this motto, five sessions - each with top-class speakers and moderators - will concentrate on the following topics: - Session 1: Worldwide GMP-Inspections
- Session 2: New Concepts for the Quality Unit
- Session 3: How to establish a company-wide Quality Risk Management System
- Session 4: New EU and FDA Requirements on Qualification and Validation
- Session 5: How to develop Quality Agreements which meet Industry and Authority needs
The conference will also deal with the consequences of the revision of EU GMP Guide Chapter 5 (Production) - in particular the Supplier Qualification topic. The EU GMP Guide requires clear guidance regarding the separation of responsibilities between contract giver and contract acceptor. As a participant of Session 5 "Quality Agreements" you will benefit from concrete support through extra sample contracts on the topics: - Transport of medicinal products
- Contract manufacturing of medicinal products
- Contract manufacturing of medical devices
- Contract manufacturing of foostuffs
- Contract testing of medicinal products
- Sourcing starting materials
All our contracts are practice-oriented and precisely describe GMP aspects which both contract giver and contract acceptor have to meet. These contracts have been elaborated by the German Federal Association of Drug Manufacturers (Bundesverband der Arzneimittelhersteller - BAH) in Bonn. Please also see the GMP Conference website for further information. Author:
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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