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 21.08.2019

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 21

FDA's Answers to questions on GMP-compliant Chromatography in the Quality Contro ...

The FDA has clear expectations about cGMP compliance in an analytical laboratory. Read more about what the cGMP-compliant running of chromatographic systems in a quality control laboratory should look like.

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Aug 21

What is a Combination Product? ...

The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).

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Aug 21

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 21

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 21

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 has been 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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Upcoming Conferences and Courses

Audit Trail Review

Copenhagen, Denmark
27 August 2019

Audit Trail Review
Data Integrity - Requirements for a GMP-compliant Data Life Cycle

Copenhagen, Denmark
28-30 August 2019

Data Integrity - Requirements for a GMP-compliant Data Life Cycle
Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review

Copenhagen, Denmark
27-30 August 2019

Data Integrity - Requirements for a GMP-compliant Data Life Cycle & full-day pre-course session Audit Trail Review
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14th Qualified Person Forum

Recommended Event

Munich, Germany

28-29 November 2019

14th Qualified Person Forum

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training

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Guidelines say?

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GMP App

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