ECA Foundation

ECA's 6th Annual Review (2004)


22 February 2005

Annual Review 2004

Membership

With 2,824 members, ECA has become the leading European association with regard to GMP and FDA compliance. The members from all over Europe and abroad represent 45 countries.

ECA Annual Review 2004 - Members

GMP In-house Training - A Successful Start in 2004
The European Compliance Academy conducted a great number of in-house training courses in Europe. This new service is realised together with CONCEPT HEIDELBERG. Today, 8 GMP trainers who also give excellent lectures at ECA's open education courses and conferences guarantee a high level of quality. Find out more about the GMP In-house Training Programme.

CD-ROM "GMP Navigator" 7.0
The version 7.0 of the CD GMP Navigator will be released by end of February. Today, the number of GMP Guidelines on the CD-ROM has increased to more than 800! Guidances, recommendations as well as final rules and directives from the following authorities are on the CD-ROM:

  • FDA
  • EC
  • PIC/S
  • ICH
  • WHO
  • GHTF
This year, also the recommendations published by the Active Pharmaceutical Ingredient Committee (APIC) are included on the CD. Every participant of an ECA event will receive the CD-ROM free of charge.

GMP Certification Programme
The GMP Certification has become the leading qualification programme for GMP professionals. This enables ECA members to achieve an outstanding qualification. Today, ECA offers the following qualification levels:
  • 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
Many of the participants make use of the opportunity to take part in this GMP Certification Programme by attending 3 events. The Programme will be extended considerably again in 2005.

ECA Working Programme 2003 and 2004
Also in the future, ECA will 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 carry on offering all of the services free of charge to our members.

Advisory Board Members
Also in 2005, we were able to extend the ECA activities through the work of our Advisory Board with members from the industry, associations and authorities. The Advisory Board members are:

Active pharmaceutical ingredients

Matt Moran, IPCMF, 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, MicroSafe B.V., Netherlands

Quality Assurance

Dick Bonner, Eli Lilly, United Kingdom

Regulatory Affairs

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

FDA Compliance

Daniel Scheidegger, Genzyme Pharmaceuticals, Switzerland

 
Author:
Dr Peter Reichelt
Chairman, European Compliance Academy

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