Weekly GMP Newsletter

NEW SERVICE: the weekly Newsletter is now available here.

Read the GMP Newsletter dated 19.06.2019

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

Jun 26

Deletion of Data: Does it have to be regulated in a SOP? ...

The data integrity topic raises a number of questions. Current questions are addressed in a loose sequence of News. Question 4: Does the deletion of data have to be regulated in a SOP?

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Jun 26

How to prepare for Russian Inspections ...

Quite a few authorities in the health care sector come for GMP inspections also to foreign countries. Here you can read what Russian inspectors will expect.

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Jun 26

Warning Letter for US Pharmaceutical Manufacturer: Container/Closure Issues and ...

The US FDA has recently published a Warning Letter describing the deficiencies observed during an inspection performed in September 2018 at a US pharmaceutical manufacturer. One serious deficiency concerns leaking product containers. Furthermore, defects in the stability programme, in the CAPA system and in data integrity have also been reported.

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Jun 24

MHRA reports serious GCP breaches including Data Integrity ...

The British Medicines and HealthCare Regulatory Agency (MHRA) recently published the 2018 metrics report for serious GCP breaches reported to the agency.

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Jun 24

The ICH publishes E8(R1) Draft Guideline for comment ...

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

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Jun 19

FDA Blockchain Pilot ...

The US FDA has selected four companies to participate in a pilot evaluating blockchain technology to enhance supply chain security.

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Upcoming Conferences and Courses

Impurities Forum 2019 - Part I - General Strategies for Investigation and Control

Praha, Czech Republic
26 June 2019

Impurities Forum 2019 - Part I - General Strategies for Investigation and Control
GMP for Advanced Therapy Medicinal Products

Vienna, Austria
26/27 June 2019

GMP for Advanced Therapy Medicinal Products
Impurities Forum 2019 Part II - Elemental and Genotoxic Impurities

Praha, Czech Republic
27 June 2019

Impurities Forum 2019 Part II - Elemental and Genotoxic Impurities
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