Annual Review 2004

GMP News No. 521

GMP News
22 February 2005

Annual Review 2004


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

GMP In-house Training - A Successful Start in 2004

The European Compliance Academy conducteda great number of in-house training courses in Europe. Thisnew service is realised together with CONCEPT HEIDELBERG. Today, 8 GMP trainers who also give excellentlectures at ECA's open education courses and conferences guarantee a highlevel of quality.

CD-ROM "GMP Navigator" 7.0

The version 7.0 of the CD GMP Navigatorwill be released by end of February. Today, the number of GMP Guidelineson the CD-ROM has increased to more than 800! Guidances, recommendationsas well as final rules and directives from the following authorities areon the CD-ROM:

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

This year, also the recommendationspublished by the Active Pharmaceutical Ingredient Committee (APIC) areincluded 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 theleading qualification programme for GMP professionals. This enables ECAmembers to achieve an outstanding qualification. Today, ECA offers thefollowing qualification levels:

  • ECA Certified Quality AssuranceManager - Pharmaceutical Production -
  • ECA Certified Quality AssuranceManager - API Production -
  • ECA Certified Quality Control Manager
  • ECA Certified PharmaceuticalEngineering Manager
  • ECA Certified Computer ValidationManager
  • ECA Certified Regulatory AffairsManager

Many of the participants make use of theopportunity to take part in this GMP Certification Programme by attending 3 events.The Programme will beextended considerably again in 2005.

ECA Working Programme 2003 and 2004

Also in the future, ECA will dependexclusively on the voluntary work of its members and Advisory Boardmembers. Only because of this support and the co-operation with CONCEPTHEIDELBERG is it possible for us to carry on offering all of the servicesfree of charge to our members.

Advisory Board Members

Also in 2005, we were able to extend theECA activities through the work of our Advisory Board with members fromthe industry, associations and authorities. The Advisory Board membersare:

Activepharmaceutical ingredients

MattMoran, IPCMF, Ireland

Computervalidation (incl. Part 11)

DrW. Schumacher, F.Hoffmann-La Roche, Switzerland


RudolfVöller, Regierungspräsidium Darmstadt, Germany

JohnTaylor, MHRA, UnitedKingdom

Analyticalquality control 

DrLudwig Huber, AgilentTechnologies, Germany

DrBernd Renger, Vetter Pharma-Fertigung GmbH,Germany

Microbiologicalquality control

ColinBooth, Oxoid Ltd, United Kingdom

MikeEdgington, MicroSafe B.V., Netherlands


DickBonner, Eli Lilly, UnitedKingdom


DrBoris Pimentel, DNP (DSM-Nutritional Products), Switzerland


DanielScheidegger, Genzyme Pharmaceuticals, Switzerland

Dr Peter Reichelt
Chairman, European Compliance Academy


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