ECA´s New Qualification & Validation Guide

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Weekly GMP Newsletter

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Read the GMP Newsletter dated 11.09.2019

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 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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Sep 11

Media Fill and Aseptic Behaviour in Focus of FDA Warning Letter ...

Significant deficiencies in the pharmaceutical quality management system led to a Warning Letter to the American company Akorn. What deviations in media fill and aseptic behavior were detected in the inspected company?

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Sep 11

Track & Trace: Still ongoing issues ...

It has hardly worked out anywhere: the falsification protection project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.

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Sep 04

USP Packaging Standards ...

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

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Sep 04

EMA publishes first two Guidances on Drug Shortages ...

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published two guidance documents which can be seen as foundation for a long way to diminish shortages of medicinal products.

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Sep 04

Fundamental GMP Deficiencies at US-American Pharmaceutical Manufacturer ...

During the inspection of a pharmaceutical manufacturer in the USA, the FDA discovered fundamental GMP deficiencies which concern - among other things - cleaning of equipment, cleaning validation, the water system and the stability programme.

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Upcoming Conferences and Courses

D.I.C.T. - Data Integrity in Clinical Trials

Copenhagen, Denmark
17/18 September 2019

D.I.C.T. - Data Integrity in Clinical Trials
Bioassays and Bioanalytics

Copenhagen, Denmark
17/18 September 2019

Bioassays and Bioanalytics
Modern Microbiology Laboratory<br>Pharmacopoeial and GMP Compliance

München, Germany
17-19 September 2019

Modern Microbiology Laboratory Pharmacopoeial and GMP Compliance
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Validation of Analytical Test Procedures & Measurement Uncertainty

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Praha, Czech Republic

31. März - 02. April 2020

Validation of Analytical Test Procedures & Measurement Uncertainty

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