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Membership
The European Compliance Academy (ECA) is still the leading European
association with regard to GMP and FDA compliance. End of 2005, close to
3.000 members represented 44 countries from all over Europe and
abroad.
GMP In-house Training – Continued Success in 2005
As in the years before, the European Compliance Academy also conducted
a great number of in-house training courses in 2005. This service is
realised together with CONCEPT HEIDELBERG. For all In-house trainings the
ECA relies on a pool with high-level speakers who specialised in various
areas and who are professionally, methodically and didactically top
qualified – guaranteeing high quality trainings. To find out more about
In-house training, please click here.
CD-ROM "GMP Navigator" 8.0
Traditionally, the GMP Navigator CD-ROM is a very unique and
useful tool. The new version 8.0 was issued in March and contains more
than 800 guidelines from
- FDA,
- EC,
- PIC/S,
- ICH,
- WHO and
- GHTF,
comprising several thousand pages of regulations. It also holds the FDA
Warning Letters from the past 3 fiscal years. A comfortable search
function allows users to browse the complete CD content by key words and
to directly retrieve guidelines and regulations they are specifically
interested in.
Every participant of an ECA event will receive the CD-ROM free of
charge.
GMP Certification Programme
In the past years, many professionals took advantage of ECA's high
quality GMP Certification Programme to advance their knowledge and to get
an additional qualification – making our programme the leading education
service for GMP professionals. Today, ECA offers the following
qualification levels:
- ECA Certified Validation Manager
- 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
As in the previous years we'll further develop the programme to offer
new certifications.
ECA Working Programme 2005
The ECA will continue to 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 offer
all of the services free of charge to our members.
Advisory Board Members
In 2005, we were again able to extend the ECA activities through the
work of our Advisory Board with members from the industry, associations
and authorities. For instance, in addition to extending the ECA
Certification Programme we also initiated the founding of the first ECA
Working Group on Rapid Microbiological Methods (RMM), a unique group in
Europe with the goal to exchange knowledge and opinions between industry
and regulatory authorities on an expert level.
The Advisory Board Members are:
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