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

Dec 10

GDP Association updates Code of Practice for the Responsible Person for GDP ...

The Code of Practice "The Responsible Person for GDP" has been revised. The new Version 2 has just beed issued for members of the European GDP Association.

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Dec 06

New ICH Topic M11 CeSHarP ...

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH M11 guideline Clinical electronic Structured Harmonized Protocol (CeSHarP).

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Dec 06

FDA allows greater flexibility for clinical investigators about informed consent ...

The FDA proposes to allow greater flexibility for clinical investigators about informed consent in minimal risk situations. Read more about Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.

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Dec 06

Dose Escalation - is it GCP compliant? ...

On the MHRA Inspectorate blog a new post has just been published emphasizing that according to GCP dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Read more about "Dose Escalation - is it GCP compliant?"

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Dec 03

New ICH Topic Q14 and Revision of Q2 ...

A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.

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Dec 03

PIC/S gives ECA the Opportunity to comment on PI 041-1 (Draft 3) - Data Integrit ...

The Pharmaceutical Inspection Co-operation Scheme as international association of pharmaceutical inspectors is currently elaborating a document on data integrity. This document was published for comment on 30 November 2018. Among others, the ECA Foundation has been given the opportunity by the PICS to comment on this third draft by 28 February 2019. Read more about the new draft 3 of PI 041-1 "Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments".

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Upcoming Conferences and Courses

Pharmacopoeias for Beginners - How to work with the compendia (USP & Ph.Eur.)

Barcelona, Spain
11-12 December 2018

Pharmacopoeias for Beginners - How to work with the compendia (USP & Ph.Eur.)
GMP Webinar: Deviations and CAPA Management - What to do and how to do


Thursday, 13 December 2018, 15.00 – 16.30 h

GMP Webinar: Deviations and CAPA Management - What to do and how to do
Audit Trail Review

Berlin, Germany
11 December 2018

Audit Trail Review
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Cleaning Validation

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Prague, Czech Republic

6-7 February 2019

Cleaning Validation

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