GMP and FDA compliant Quality and Documentation Systems 30-31 October 2008 Vienna, Austria 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 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1606,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives During this Education Course you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from API and pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and (c)GMP-compliant. Background: Various Quality and Documentation Systems exist in the pharmaceutical industry. Their common aim is to ensure product quality and safety. These systems are not stand alone systems. They are all linked to each other: A Deviation causes a Failure Investigation which is followed by a CAPA that could lead to a Change and Change Control. All need to be documented in the PQR or APR. Also, the inspectorates are aware that only a well structured organisation is capable of dealing with the task of bringing together and evaluating all relevant information. Recent initiatives and guidances like ICH Q10 and FDA's Guidance for Industry "Quality Systems Approach to Pharmaceutical CGMP Regulations" facilitate the modernisation of drug manufacturing. Hence, (c)GMP-compliant quality and documentation systems are of extreme importance for the manufacturing of safe high quality products. The companies should have all these systems in place; let's find out how we can get the most out of them!