ICH Q9 Training Course and ICH Q10 Training Course Save up to EUR 600,- and book both courses simultaneously! 21-23 April 2010 Budapest, Hungary 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 1980,--) Book this option: ECA Members (EUR 1782,--) Book this option: EU GMP Inspectorates (EUR 990,--) Book this option: APIC Members (does not include ECA membership) (EUR 940,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
ICH Q9 Training Course The Guideline ICH Q9 "Quality Risk Management" was finalised in November 2005 (Step 5). Consequently, this guideline has to be implemented in the EU, the US (FDA) and in Japan. The ICH Q9 training course in hand deals with the practical implementation of the requirements. Individual examples help to show the application in the following GMP areas: - Validation - Change Control/Change Management - Auditing/Inspections - Quality Systems ICH Q10 Training Course As a complement to the lectures, the closing workshop offers the opportunity to practise Quality Risk Management techniques with a case study. 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.