Annual Review 2003

GMP News No. 384

GMP News
9 February 2004
 

 
Number of Members

The number of members of the European Compliance Academy (ECA) increased also in 2003. Currently, ECA has 2,578 members from 45 countries.
  

 
GMP In-house Training - A New Service for 2004

The European Compliance Academy has received many enquiries for the conduct of GMP in-house training courses. This new service is going to be realised together with CONCEPT HEIDELBERG. For this task, we were able to win 7 GMP trainers who also give excellent lectures at ECA's open education courses and conferences. If you would like to know more about this offer, please click here.

CD-ROM "GMP Navigator" 6.0

Also in 2004, a new release of the GMP Navigator guideline CD-ROM will appear (planned for 15 February 2004). From that date the CD will be handed out at every ECA event. Within the framework of the extension, apart from the guidelines published by the FDA, EU, ICH, and GHTF, the new GMP guidelines issued by WHO are also included on the CD-ROM. As in earlier releases, all guidelines on the CD-ROM are displayed in a clearly-arranged tree structure. The full-text search of all documents will again be available.

GMP Certification Programme - 
Europe's Leading Qualification Programme for GMP Professionals

The GMP Certification Programme enables interested persons to acquire the following certificates:

  • 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. We are happy about the good response! Therefore, the Programme will be extended considerably again in 2004.

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 2003, 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

Dr N. Franklin, Interactive Consulting, Germany

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, UK

Analytical quality control 

Dr Ludwig Huber, Agilent Technologies, Germany

Dr Bernd Renger, Vetter Pharma-Fertigung GmbH, Germany

Microbiological quality control

Mike Edgington, MicroSafe B.V., Netherlands

Quality Assurance

Dick Bonner, Eli Lilly, UK

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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