Press Announcements 2017

Consequences of the new FDA/EU MRA agreement on GMP Inspection

The new MRA agreement between the EU and the US will already come into force on 1st November of this year. However, the implementation will cause a number of questions in practice. Maria-Jesus Alcaraz from EMA will present first-hand information at the 7th European GMP Conference on 31. May - 01. June 2017 in Prague. This event is organised only every two years by the ECA Academy, the European QP Association and several additional Interest Groups. More details about this unique event with delegates more than 20 countries can be found at www.gmp-conference.org

Ensuring the Integrity of Production Data

Data integrity is one of the hottest topics currently discussed. This is also why public authorities have been paying more attention to the issue recently - as an impressive number of Warning Letters and Non-Compliance Reports have clearly shown in the last months. But what are the actual requirements of FDA, EU, WHO and PIC/S? What is demanded by management and personnel in production in terms of data governance? You can learn more about this at the Manufacturing Data Integrity conference as part of this year's Pharma Congress on 28/29 March in Düsseldorf. There you will also find out how the data life cycle in production is linked to business processes. Please see the Pharma Congress website for further information.

New ECA Academy Webpage - New Features and Services for Members

You may have already visited our new ECA Academy Webpage. For your convenience we tried to structure the webpage very similar to the previous version. But there are some changes for the benefit of the ECA Members. You will find the GMP Guideline Manager there and also all FDA Warning Letter related to GMP issues in a structured form. The GMP Discussion Forum moved to the ECA Members Area as well. This will allow the ECA Members to discuss their GMP questions in a closed community. Further information has been added like "Top Lectures" where you can access presentations which received a very high interest (e.g. presentations form EU and FDA Inspectors). And all articles from the GMP Journal can be accessed there as well. We recommend to login into the ECA Members Area

GMP Conferences by Topics

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