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GMP News
21 August 2006
 

Annual Review 2005

 
Membership

The European Compliance Academy (ECA) is still the leading European association with regard to GMP and FDA compliance. End of 2005, close to 3.000 members represented 44 countries from all over Europe and abroad.

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GMP In-house Training – Continued Success in 2005

As in the years before, the European Compliance Academy also conducted a great number of in-house training courses in 2005. This service is realised together with CONCEPT HEIDELBERG. For all In-house trainings the ECA relies on a pool with high-level speakers who specialised in various areas and who are professionally, methodically and didactically top qualified – guaranteeing high quality trainings. To find out more about In-house training, please click here.

CD-ROM "GMP Navigator" 8.0

Traditionally, the GMP Navigator CD-ROM is a very unique and useful tool. The new version 8.0 was issued in March and contains more than 800 guidelines from

  • FDA,
  • EC,
  • PIC/S,
  • ICH,
  • WHO and
  • GHTF,

comprising several thousand pages of regulations. It also holds the FDA Warning Letters from the past 3 fiscal years. A comfortable search function allows users to browse the complete CD content by key words and to directly retrieve guidelines and regulations they are specifically interested in.

Every participant of an ECA event will receive the CD-ROM free of charge.

GMP Certification Programme

In the past years, many professionals took advantage of ECA's high quality GMP Certification Programme to advance their knowledge and to get an additional qualification – making our programme the leading education service for GMP professionals. Today, ECA offers the following qualification levels:

  • ECA Certified Validation Manager
  • ECA Certified Quality Assurance Manager – Pharmaceutical Production –
  • ECA Certified Quality Assurance Manager – API Production –
  • ECA Certified Quality Control Manager
  • ECA Certified Pharmaceutical Engineering Manager
  • ECA Certified Computer Validation Manager
  • ECA Certified Regulatory Affairs Manager

As in the previous years we'll further develop the programme to offer new certifications.

ECA Working Programme 2005

The ECA will continue to depend exclusively on the voluntary work of its members and Advisory Board members. Only because of this support and the co-operation with CONCEPT HEIDELBERG is it possible for us to offer all of the services free of charge to our members.

Advisory Board Members

In 2005, we were again able to extend the ECA activities through the work of our Advisory Board with members from the industry, associations and authorities. For instance, in addition to extending the ECA Certification Programme we also initiated the founding of the first ECA Working Group on Rapid Microbiological Methods (RMM), a unique group in Europe with the goal to exchange knowledge and opinions between industry and regulatory authorities on an expert level.

The Advisory Board Members are:
 

Active pharmaceutical ingredients

Matt Moran, PharmaChemical, Ireland

Computer validation (incl. Part 11)

Dr W. Schumacher, F. Hoffmann-La Roche, Switzerland

GMP supervision 

Rudolf Völler, Regierungspräsidium Darmstadt, Germany

John Taylor, MHRA, United Kingdom

Analytical quality control 

Dr Ludwig Huber, Agilent Technologies, Germany

Dr Bernd Renger, Vetter Pharma-Fertigung GmbH, Germany

Microbiological quality control

Colin Booth, Oxoid Ltd, United Kingdom

Mike Edgington, Edgington Associates, Netherlands

Quality Assurance

Dick Bonner, Associate Partner CONCEPT HEIDELBERG, United Kingdom

Regulatory Affairs

Dr Boris Pimentel, DNP (DSM-Nutritional Products), Switzerland

FDA Compliance

Daniel Scheidegger, Genzyme Pharmaceuticals, Switzerland

 
Author:
Daniel Scheidegger
Chairman, European Compliance Academy (ECA)
 

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