Annual Review 2003

GMP News No. 384

GMP News
9 February 2004
 

 
Number of Members

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

 
GMP In-house Training - A New Service for 2004

The European Compliance Academy hasreceived many enquiries for the conduct of GMP in-house training courses. Thisnew service is going to be realised together with CONCEPT HEIDELBERG. For this task,wewere able to win 7 GMP trainers who also give excellentlectures at ECA's open education courses and conferences.

CD-ROM "GMP Navigator" 6.0

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

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

The GMP Certification Programmeenables interested persons to acquire the following certificates:

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

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 2003, 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

DrN. Franklin, Interactive Consulting, Germany

MattMoran, IPCMF, Ireland

Computervalidation (incl. Part 11)

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

GMPsupervision 

RudolfVöller, Regierungspräsidium Darmstadt, Germany

JohnTaylor, MHRA, UK

Analyticalquality control 

DrLudwig Huber, AgilentTechnologies, Germany

DrBernd Renger, Vetter Pharma-Fertigung GmbH,Germany

Microbiologicalquality control

MikeEdgington, MicroSafe B.V., Netherlands

QualityAssurance

DickBonner, Eli Lilly, UK

RegulatoryAffairs

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

FDACompliance

DanielScheidegger, Genzyme Pharmaceuticals, Switzerland

 
Author:
Dr Peter Reichelt
Chairman, European Compliance Academy
   

 

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