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 18.09.2019

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

Sep 18

New FDA guidance on Child-Resistant Packaging ...

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

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Sep 18

No more FDA Inspections in the EU - really? ...

The Mutual Recognition Agreement (MRA) between the EU and the US is now in force as planned. But does this really mean the end of all FDA Inspections in the EU?

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Sep 18

Warning Letter due to Cross Contamination ...

In August, the US FDA issued a Warning Letter due to cross-contamination with penicillin in areas for non-beta-lactam production.

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Sep 18

New Ph. Eur. chapter on statistical process control (SPC) planned ...

Process controls have become customary in pharmaceutical processes. The aim is to monitor a process and improve it if possible. Statistical process control (SPC) is viewed as one option to implement Ongoing/Continued Process Verification. PharmEuropa has now published a new draft chapter on the topic.

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Sep 18

GMP for Radiopharmaceuticals - WHO/IAEA Guideline open for comments ...

In July, the WHO and the IAEA published a draft guideline for the specific GMP requirements for the manufacture and control of radiopharmaceuticals, which can be commented until 20 September.

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Sep 11

No Documentation in the Inspection? Not a good Idea! ...

A company in China has created GMP documents only for the purpose of inspection. With serious consequences.

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Upcoming Conferences and Courses

The GDP Compliance Manager

Barcelona, Spain
24-26 September 2019

The GDP Compliance Manager
Pharmaceutical Biotechnology for Non-Biotechnologists

Berlin, Germany
24/25 September 2019

Pharmaceutical Biotechnology for Non-Biotechnologists
Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals

Berlin, Germany
24/25 September 2019

Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals
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Computer Validation: Introduction to Risk Management + GAMP 5 Approach - Save up to EUR 490,- by booking both courses!

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Vienna, Austria

31. März - 03. April 2020

Computer Validation: Introduction to Risk Management + GAMP 5 Approach - Save up to EUR 490,- by booking both courses!

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