ECA´s New Qualification & Validation Guide

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Weekly GMP Newsletter

NEW SERVICE: the weekly Newsletter is now available here.

Read the GMP Newsletter dated 14.08.2019

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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GMP/GDP Training Matrix

GMP/GDP Training Matrix

Are you looking for certain GMP/GDP Training Courses? The GMP/GDP Matrix will help you find your training course.

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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

Aug 20

Warning Letter due to Deficiencies in the Purified Water System ...

In June, a US-American pharmaceutical manufacturer received a Warning Letter from the FDA due to deficiencies in the Purified Water System which concern - among other things - the design of the water system, monitoring, sampling and handling of CAPAs.

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Aug 20

MRA: Can Import Testing be completely stopped now? ...

The MRA with the USA is now in force as planned. But there is a lot to be considered in order to stop import testing.

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Aug 20

ISPE publishes revised Guideline on Commissioning and Qualification ...

The ISPE Baseline Guide Vol. 5 on Commissioning & Qualification has been in place since 2001 and was thus no longer up to date. Recent developments, e.g. towards a lifecycle model, were not reflected in the document. Now the ISPE Baseline Guide Vol. 5 was completely revised. 

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Aug 19

How to quickly find out about FDA requirements for Medical Devices? ...

In the USA, medical devices are regulated within the FDA by the Center for Devices and Radiological Health (CDRH). How can one quickly familiarize oneself with the topic of "medical devices" or stay up to date? For this purpose, the FDA offers an own website: CDRH Learn.

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Aug 19

Experiential Learning Program of the CDRH ...

Under the heading "CDRH's Experiential Learning Program", the FDA offers an interesting advanced training program. It is aimed at FDA employees who are "reviewers", i.e. who evaluate medical devices as part of the "approval procedure". The idea behind the program is...

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Aug 19

FDA Feedback after an Inspection at a Medical Device Manufacturer ...

In a draft guideline, the FDA informs that in future they will offer (nonbinding) feedback following an FDA inspection at a medical device manufacturer. What does this mean?

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