KPIs and Quality Metrics – with speaker Alex Viehmann, FDA!

From 7-8 March 2019 in Prague

Discuss the latest expectations and requirements for Quality Metrics and KPIs and how they are linked to Continual Quality Improvement (CQI) and Business Continuity.

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20 Years ECA Academy

From 6-7 June 2019 in Heidelberg, Germany

Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference
- Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends
- Receive the latest ECA Guidance Documents at no costs!

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Pharma Congress 2019

From 9-10 April 2019 in Düsseldorf, Germany
- More than 60 Speakers from pharmaceutical companies and GMP Inspectorates
- Case Studies from Novartis, Roche, Boehringer Ingelheim, Sanofi, Bayer, Pfizer and many more
- 3 GMP/FDA Conferences – create your own agenda!

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Acknowledged GMP/GDP Certification

Highly qualified personnel is crucial in the pharmaceutical industry. The ECA Certification scheme with 14 continuous education programmes trains you adequately.

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ECA Annual Report 2018

Read more about a unique success story of Europe´s leading GMP/GDP Association

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ECA – Your GMP/GDP Information Source

With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.

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Latest GMP News

Feb 20

EU-FDA MRA to be expanded ...

The scope of the EU-FDA Mutual Recognition Agreement (MRA) will be extended to veterinary medicinal products, human vaccines and plasma derivatives.

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Feb 20

New WHO Guideline on "Cold Production of WFI" ...

In February 2019, the WHO published a new Guideline for comment on the production of WFI using non-distillation methods. Read more about the draft entitled "Production of Water for Injection by Means other than Distillation".

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Feb 20

Brexit: Safety Features & Multi-Country Packs ...

Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published  the answer to this and other related questions.

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Feb 20

EMA's Reflection Paper on the Qualification of Non-Genotoxic Impurities ...

Data from pre-clinical/clinical studies are often not sufficient for a comprehensive qualification of impurities with regard to their biological safety profile. The new EMA Reflection Paper provides guidance for determining the safety profile of impurities by means of various methods.

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Feb 20

Final FDA Guidance on Public Warning and Notification of Recalls ...

The FDA strengthens the process for issuing a public warning about a voluntary recall and for notification of recalls. Read more about FDA´s final guidance on Public Warning and Notification of Recalls.

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Feb 20

US Track and Trace System ...

The FDA launched the development of an enhanced electronic, interoperable U.S. track-and-trace system for industry set to go into effect in 2023.

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