Annual Review 2005

GMP News No. 774

GMP News
21 August 2006
 

Annual Review 2005

 
Membership

The European Compliance Academy (ECA) is still the leading Europeanassociation with regard to GMP and FDA compliance. End of 2005, close to3.000 members represented 44 countries from all over Europe andabroad.

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GMP In-house Training – Continued Success in 2005

As in the years before, the European Compliance Academy also conducteda great number of in-house training courses in 2005. This service isrealised together with CONCEPT HEIDELBERG. For all In-house trainings theECA relies on a pool with high-level speakers who specialised in variousareas and who are professionally, methodically and didactically topqualified – guaranteeing high quality trainings. To find out more aboutIn-house training, please click here.

CD-ROM "GMP Navigator" 8.0

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

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

comprising several thousand pages of regulations. It also holds the FDAWarning Letters from the past 3 fiscal years. A comfortable searchfunction allows users to browse the complete CD content by key words andto directly retrieve guidelines and regulations they are specificallyinterested in.

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

GMP Certification Programme

In the past years, many professionals took advantage of ECA's highquality GMP Certification Programme to advance their knowledge and to getan additional qualification – making our programme the leading educationservice for GMP professionals. Today, ECA offers the followingqualification levels:

  • ECA Certified Validation Manager
  • ECA Certified Quality Assurance Manager – PharmaceuticalProduction –
  • 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 offernew certifications.

ECA Working Programme 2005

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

Advisory Board Members

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

The Advisory Board Members are:
 

Activepharmaceutical ingredients

Matt Moran, PharmaChemical, Ireland

Computervalidation (incl. Part 11)

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

GMPsupervision 

RudolfVöller, Regierungspräsidium Darmstadt, Germany

JohnTaylor, MHRA, United Kingdom

Analyticalquality control 

DrLudwig Huber, Agilent Technologies, Germany

DrBernd Renger, Vetter Pharma-Fertigung GmbH, Germany

Microbiologicalquality control

Colin Booth, Oxoid Ltd,United Kingdom

Mike Edgington, Edgington Associates,Netherlands

QualityAssurance

Dick Bonner, Associate Partner CONCEPT HEIDELBERG, United Kingdom

RegulatoryAffairs

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

FDACompliance

DanielScheidegger, Genzyme Pharmaceuticals, Switzerland

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

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