Prague, Czech Republic
Course No 15959
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Richard Bonner, Qualified Person and Chairman ECA, UK
Dr Christopher Burgess, Qualified Person and Chairman of ECA‘s Quality Control Working Group, UK
Klaus Eichmüller, Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Dr Matthias Heuermann, NRW Centre for Health (LZG.NRW), Münster, Germany
Dr Afshin Hosseiny, Qualified Person and Chairman of ECA‘s GDP
Interest Group, UK
Dr Andreas König, Quality König GmbH, Germany
Oliver Küttner, Shire, Austria
JOHANNA LINNOLAHTI, Finnish Medicines Agency FIMEA, Finland
Gert Mølgaard, Chair of ECA‘s Working Group on Validation, Denmark
Tracy Moore, Medicines and Healthcare Products Regulatory Agency, UK
Dr Bernd Renger, Qualified Person and Immediate Past Chair of the EQPA, Germany
Dr Franz Schönfeld, GMP Inspectorate, Germany
Dr Wolfgang Schumacher, Chairman ECA´s IT Compliance Group, Switzerland
Lance Smallshaw, ECA Executive Board Member, Belgium
The EU GMP Conference is only offered every two years. This unique conference will discuss current and planned changes to the GMP regulation. All experts and managers involved in GMP compliance activities will have the opportunity to get a comprehensive GMP update and to talk to the leading experts from industry and authority.
Although EU GMP is in the center of attention, a harmonized approach with cGMP from FDA will also be an important aspect of the agenda. For international operating companies both EU GMP and FDA compliance is important and the corporate quality systems need to cover the regulation of both regions.
The agenda will therefore focus on key GMP compliance developments. Attention will be paid on the implementation of these requirements into pharmaceutical quality systems. The ECA Foundation’s objective is to support industry, and therefore current activities as well as guidance documents and SOPs are presented during this conference.
Each Session will have speakers from industry and inspectorates to discuss both expectations and implementation aspects.
We wish you a successful and interesting conference.
Richard M. Bonner
Chairman of the ECA Advisory Board
The conference is of particular interest for GMP experts of pharmaceutical companies (e.g. QA, QC, production, distribution, regulatory affairs, validation), of GMP inspectorates and Regulatory Authorities.
ECA Guidance Document on Data Integrity
ECA Guidance Document on OOE and OOT
ECA Good Practice Guide on Validation Version 02
ECA/PQG Guide on Good Distribution Practice
Session I Current Initiatives in EU and FDA
This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP regulation
Update from recent EU GMP changes