Weekly GMP Newsletter

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Read the GMP Newsletter dated 15.05.2019

20 Years ECA Academy

From 6-7 June 2019 in Heidelberg, Germany

Join us and celebrate the 20 years anniversary of ECA in Heidelberg at the 8th European GMP Conference
- Meet speakers from US FDA, EU GMP Inspectorates and Pharmaceutical Industry to hear the latest GMP Trends
- Receive the latest ECA Guidance Documents at no costs!

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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 – 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

May 21

Recent GMP defects in process validation ...

What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.

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May 21

Fundamental GMP defects by manufacturer of homeopathic drugs ...

Due to fundamental GMP deficiencies, the FDA has issued a Warning letter to a US manufacturer of homeopathic drugs. Read more here.

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May 16

GDP-Inspector: Why Supplier Qualification is important ...

The MHRA explains in a Blog what supplier qualification means and why it is necessary to do it comprehensively.

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May 16

New office-based GDP-Inspection Process in UK ...

The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based GDP-Inspection process - without a visit of the site. 

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May 15

Warning Letter on Data Integrity Issues in the Microbiological Laboratory ...

Among other things, insufficient or missing reports of test results in a microbiological laboratory resulted in a Warning Letter addressed to the company concerned. Read more about the Warning Letter to Hospira Healthcare India Pvt.

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May 15

How does the GDPR impact Clinical Trials? ...

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

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Upcoming Conferences and Courses

HPLC Data Integrity & Workshop Audit Trail Review for CDS/Laboratory Systems

Berlin, Germany
22-24 May 2019

HPLC Data Integrity & Workshop Audit Trail Review for CDS/Laboratory Systems
HPLC Data Integrity

Berlin, Germany
23-24 May 2019

HPLC Data Integrity
ECA Webinar: Microbiological Control of Non-Sterile Drug Products and Raw Materials

Heidelberg, Germany
Thursday, 23 May 2019 14.00 - 15.30 h

ECA Webinar: Microbiological Control of Non-Sterile Drug Products and Raw Materials
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Data Integrity Master Class

Recommended Event

Copenhagen, Denmark

5-7 June 2019

Data Integrity Master Class

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training

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Overview about all the courses and conferences, including infos on location, date, fees and the detailed agenda.

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What do the
Guidelines say?

Make yourself familiar with what the Guidelines say and get to all important Authority Guidelines.

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GMP App

All GMP information on your smartphone or Tablet PC – with the new free of charge ECA GMP WebApp.

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GMP Conferences by Topics

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