Im Auftrag der European Compliance Academy ICH Q10 Training Course 21-22 October 2010 Prague, Czech Republic Bitte klicken Sie hier, um das Seminarprogramm anzuschauen. Um sich zu diesem Seminar anzumelden, klicken Sie einfach auf die entsprechende Option: Seminar buchen: Non-ECA Members (EUR 1290,--) Seminar buchen: ECA Members (EUR 1161,--) Seminar buchen: EU GMP Inspectorates (EUR 645,--) Seminar buchen: APIC Members (does not include ECA membership) (EUR 1225,--)
Bei diesem Seminar wird eine Fachausstellung angeboten. Klicken Sie hier, um das Faxformular für die Anmeldung zur Fachausstellung zu öffnen.
FDA's Final Report "Pharmaceutical cGMPs for the 21st Century " A Risk-based Approach brings about a great number of changes. One key document is the FDA Guidance for Industry: Quality System Approach to Pharmaceutical cGMP. In parallel, the International Conference on Harmonisation has published the Guidance ICH Q10 Pharmaceutical Quality Systems. The course in hand will provide you with information on the content and consequences of these documents. The following topics will be covered: - Modern management concepts, like CAPA - Risk management in quality systems - Continuous improvement - ISO 9001 in the GMP environment In addition the topics will be further discussed in interactive workshops.