The GMP Compliance Manager 15-16 November 2012, 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 1690,--) Book this option: ECA Members (EUR 1490,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1590,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Speakers Dr Bernhard Böhm, Boehringer Ingelheim Ingo Ebeling, Abbott Products Dr Daniel Marquardt, Boehringer Ingelheim Clodagh Phelan, Ann McGee Consulting Ltd. Objectives/Background During this Education Course you will learn how the various pharmaceutical quality and documentation systems work and how they interact. Experts from the pharmaceutical industry will show you possibilities to improve your systems and how to run them efficiently and in compliance with (c)GMP. Pharmaceutical Quality Assurance and GMP Compliance Managers are continuously facing new challenges due to changing regulatory requirements and at the same time increasing needs for efficiency. In this context, GMP-Compliance Managers must be familiar with many GMP-related topics, such as: Knowledge and interpretation of Regulatory Requirements and Expectations Deviations and Failure Investigation CAPA Batch Record Review Change Control PQR / APR Documentation Systems Risk Analysis and Assessment These 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 can lead to a Change and Change Control. And all relevant information must be documented in the PQR and APR. Companies should have all these systems in place. Let's find out how we can get the most out of them!