How to Pass EU and FDA Inspections & GMP Compliance Audits 25-27 May 2011 Prague, Czech Republic 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 1990,--) Book this option: ECA Members (EUR 1790,--) Book this option: EU GMP Inspectorates (EUR 995,--) Book this option: APIC Members (does not include ECA Membership) (EUR 1890,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit. Get practical knowledge of: What inspectors are looking for Successful preparation and management of Inspections Typical compliance issues and proactive compliance Performing a MOCK-Inspection The psychology of inspections In addition you will hear trends from EU and FDA Inspections to gain a better understanding of what is expected. Sufficient time for questions and answers is provided to discuss your issues. Background GMP audits and inspections are fundamental elements of managing quality assurance in the pharmaceutical industry. On the one hand, pharmaceutical companies have to perform supplier audits. And on the other hand, the pharmaceutical companies as well as the suppliers are frequently inspected by the authorities (both national and inspectorates like the FDA) as a central element of supervision. For the company, an inspection can have a decisive influence on the daily work and its economic future. A sound and thorough preparation is an essential key to successfully pass an inspection.