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GMP NEWSLETTER

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GMP CONFERENCES AND COURSES

Have a look at all our GMP Conferences and GMP Courses here.

   

ABOUT THE ECA FOUNDATION

With close to 4,000 members the European Compliance Academy (ECA) has become the leading European association with regard to GMP and regulatory compliance. Read more.

DATABASES ON GMP INSPECTIONS

NEW: FDA Warning Letter Tree

EudraGMP database (EMA)

WHO inspections (WHOPIR)

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Two videos will allow you to get an impression about the ECA Foundation and its comprehensive services as well as about the social events as part of every course and conference - providing the ideal platform for exchanging experience and for networking. Please go here the watch the videos.

LATEST GMP NEWS

19/06/2013
Guideline on the European Drug Master File Procedure updated
The EMA Guideline on the European Drug Master File (ASMF) Procedure was updated again. Learn more about the new requirements API manufacturers and applicants will be facing.

19/06/2013
Written Confirmation: Japan on the List of "Third Countries"
Japan is the next API exporting country on the list of countries which don't need to issue "written confirmations". Read more here.

19/06/2013
Answers by EMA on the Topic Bioburden
The questions "For an aseptically produced product, where should bioburden monitoring take place?" and "What is the maximum accepted bioburden level?" are answered by EMA on its questions and answers page. Read more.

19/06/2013
WHO Guideline on Quality Risk Management finalised
With the new Technical Report (TRS 981) the WHO has published a comprehensive paper on the development of a QRM system. Read more.

19/06/2013
MHRA implements new Software for risk based Inspection Planning
Medicines regulator implements innovative software to analyse risk data and target inspection activity. Read more.

12/06/2013
GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors
EMA’s Inspectors Working Group defines concrete criteria for the quality standards of audit reports of active substances and for the qualification of auditors in its list of questions and answers updated recently. Get more detailed information on the criteria here.

ECA ACTIVITIES

14/06/2010
The ECA and the European QP Association are currently evaluating the possibility of running training courses on European GMP requirements and the role of the QP outside Europe, amongst others in the U.S.A. Please read more here.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the ECA Foundation (see also News from 14 April 2010) - comprising a non-profit educational organisation, the ECA Academy, and two non-profit interest groups. To get an update on the latest developments with regard to the ECA, please see the video address of Daniel Scheidegger, ECA Foundation Chairman - here.

04/05/2010
To allow students to attend ECA Conferences and Education Courses, the ECA Foundation now offers a Student Programme with special fees. Read more here.

21/04/2010
European Compliance Academy (ECA) nominates Dr Jean-Denis Mallet as new Advisory Board Member. Please see here for more information.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the "ECA Foundation". Get the details here.

30/03/2010
For 2010 the ECA Working Group on Rapid Microbiological Methods (RMM) has planned various activities. To find out more about the planned programme, please read here.

24/03/2010
In April 2008 the European QP Association started its shared audits initiative. Now the Association released its new database "QPSHARE", enabling QPs to find potential partners for sharing audits more easily. Read more here.

29/07/2009
As of now you can integrate the ECA website into the Google home page (gadget) and in addition use the news as RSS feed. Find out more here.

13/10/2008
As the European Compliance Academy (ECA) announced accepted Dr Sven Deutschmann his appointment as new Chairman of its Working Group for Rapid Microbiological Methods (RMM). Read more here.

22/10/2007
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate clinical studies. A new education course initiated by the ECA now covers all aspects to consider and is supported by the two industry organisations. Find out more here.

14/06/2007
ECA supports a new publication series intended to facilitate the implementation of current GMP guidelines in pharmaceutical operations. The first issue of the "GMP REPORT" covers "FDA Requirements for cGMP Compliance". Twelve Authors from the pharmaceutical industry illustrate the efficient implementation of FDA's cGMP requirements in routine operations. To get more information on the reports and the content of the first issue please see here.

02/04/2007
The Active Pharmaceutical Ingredients Committee (APIC) and the European Compliance Academy (ECA) recently signed a cooperation agreement with the goal to bundle the strengths of the two organisations’ respective areas and to maximise the benefit for the potential target audience in the industry with their activities and conferences. Find out more here.

08/03/2007
Concept Heidelberg has been analysing the FDA Warning Letters on behalf of the European Compliance Academy (ECA) since the fiscal year 2003. Now the new report on the fiscal year 2006 is available as handbook and CD. Get more information here.

19/02/2007
In addition to automatically becoming a member by participating in one of the ECA courses or conferences marked with ECA (exception: Webinars), the Academy now also offers two new membership opportunities - individual membership and company membership.

15/12/2006
The European QP Association, initiated by the ECA in July, announced that it extended its Advisory Board and nominated Dr Christopher Burgess. To find out more, please read here.

15/12/2006
ECA's Working Group on Rapid Microbiological Methods (RMM) experiences tremendous interest. Now the group offers memberships to anyone involved in RMMs. Get the details here.

30/11/2006
ECA's Rapid Microbiology Methods (RMM) Working Group, founded in 2006, currently works on a Best Practice Guide for RMMs. Now the Academy appointed an editorial review board for its guide. Get more information here.