ICH Q10Training Course 12-13 March 2009 Barcelona, Spain Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1290,--) Book this option: ECA Members (EUR 1161,--) Book this option: EU GMP Inspectorates (EUR 645,--) Book this option: APIC Members (does not include ECA membership) (EUR 1225,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
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.