European Conference on APIs

Europe's leading event on active pharmaceutical ingredients takes place on 24-26 October, 2018 in Budapest, Hungary.

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Particles in Parenterals

Main topic of this conference is the detection of particles in injectables and their evaluation during batch release and continuous process improvement. It takes place on 10-11 October, 2018 in Hamburg, Germany.

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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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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 WebAPP – standing out, outstanding

The ECA WebApp lets you have all GMP/GDP information at hand – anytime, anywhere.

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Latest GMP News

Sep 19

FDA´s draft Guidance on Post-approval Changes to APIs ...

API manufacturers who want to make changes to the API manufacturing process during an application's post-approval period should read FDA´s new draft guidance for industry: Postapproval Changes to Drug Substances.

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Sep 19

What to expect from GVP inspections? ...

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

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Sep 19

CMDh Clarifications on the Implementation of the Falsified Medicines Directive ...

In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".

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Sep 19

Pharmacovigilance: Be prepared for "Hard Brexit" ...

The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).

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Sep 12

New Questions and Answers on Safety Features - EU Q&As Version 10 published! ...

The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.

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Sep 12

What are FDA's Expectations from Contract Manufacturers? ...

In a four-page Warning Letter to a contract manufacturer who produces semi-solid OTC products, the FDA criticizes amongst others the missing tests of starting and finished products.

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Upcoming Conferences and Courses

Plastic Packaging Materials - Development, Manufacture, Use and Control

Prague, Czech Republic
20-21 September 2018

Plastic Packaging Materials - Development, Manufacture, Use and Control
USP Workshop Promotion for Enhanced Approaches for Analytical Procedure Lifecycle, September 24-25, 2018 co-sponsored by ECA (no member rates will apply)

USP Headquarters, Rockville, Maryland
September 24-25, 2018

USP Workshop Promotion for Enhanced Approaches for Analytical Procedure Lifecycle, September 24-25, 2018 co-sponsored by ECA (no member rates will apply)
Product Transfer - Organisation of a GMP-compliant Site Change

Barcelona, Spain
25-27 September 2018

Product Transfer - Organisation of a GMP-compliant Site Change
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Process Validation in the light of the revised Annex 15 and FDA Requirements

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Berlin, Germany

10-11 October 2018

Process Validation in the light of the revised Annex 15 and FDA Requirements

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