12 March 2008
Annual Review 2007
Membership - Positive Development of New Opportunities
Again, membership in the European Compliance Academy (ECA) developed very
positively. The academy's reputation and acceptance as the leading European
association with regard to GMP and FDA compliance is steadily growing. Today,
the organisation counts close to 3.600 members from almost 60 countries across
Europe and abroad, marking a nearly 20% increase compared to last year.
ECA Members as of January 2008
in order of memberships
Special mention deserves the new membership opportunities. Established in
January 2007 they enable professionals to join the organisation and to benefit
from its services without attending a course or conference. These individual and
company memberships are increasingly requested. Find more detailed information on
these ECA membership opportunities.
ECA Interest Groups Receive Growing Attention
The two interest groups established in 2006 - the ECA Rapid Microbiological
Methods (RMM) Working Group and the European QP Association -
experience a growing awareness level.
Founded with the goal to promote the acceptance and the application of advanced
microbiological methods in Europe, the RMM Working Group today counts 157
members. Find more information about the RMM Working Group.
The steadily increasing number of members from across Europe and abroad
emphasise the significance of the European QP Association established in
2006. With this membership organisation the ECA wants to provide QPs in Europe
with a common quality voice and support this important Quality function with the
support needed. Today, the organisation counts more than 900 members, and the
1000 members mark will certainly be reached in 2008. The association's success
is also shown in the attendance of the 2nd QP Forum conducted in Berlin,
Germany, last fall. More than 200 delegates from almost 30 countries attended
the forum to catch up with the latest developments.
The interest in the group is also shown in the awareness from authority side.
Last fall the European QP Association was invited to attend an EMEA Interest
Group meeting, which allowed Dr Bernd Renger, chairman of the European QP
Association, to represent the voice of QPs in Europe for the first time. Find
out more about the European QP Association.
2007 Another Good Year for GMP In-house Trainings
Similar to the years before, the European Compliance Academy conducted several
trainings in 2007. Offered in cooperation with CONCEPT HEIDELBERG, ECA in-house
trainings rely on a pool with high-level speakers who are specialised in various
areas and who are professionally, methodically and didactically top qualified -
guaranteeing high quality trainings. Find out more about GMP in-house trainings.
ECA supported many publications
FDA Warning Letters Report 2007 Issued
As in the previous years, an analysis has been conducted of the FDA Warning
Letters issued in 2007. The new CD "FDA Navigator" with handbook was
recently issued and contains the 200 most important GMP regulations,
guidelines and interpretations by the US authority, warning letters on GMP
deviations of the years 2002 to 2007, warning Letters Report with detailed
analysis, an inspection checklist based on the cGMP Guide and a lot more. A
comfortable search function allows to search all documents on the FDA
Navigator CD by keywords. Get more information about the Warning Letters Report and the FDA Navigator CD .
New Series "GMP Report" Established
ECA also supports a new publication series intended to facilitate the
implementation of current GMP guidelines in pharmaceutical operations. ECA's
partner here is the publisher Editio Cantor Verlag. The first issue of the
"GMP REPORT" covers "FDA Requirements for cGMP Compliance". Twelve Authors
from the pharmaceutical industry illustrate the efficient implementation of
FDA's cGMP requirements in routine operations. To get more information on
the reports and the content of the first issue please see the section GMP Publications on the ECA website.
New Release 10.0 of CD-ROM "GMP Guideline Manager"
The new release 10.0 of the traditionally very unique and useful tool was
recently issued. Like in the years before, this version contains abundant
guidelines from all important authorities worldwide, comprising several
thousand pages of regulations. It also holds the FDA Warning Letters from
the past 3 fiscal years. Through a comfortable search function users can
browse the complete CD content by key words and directly retrieve guidelines
and regulations they are specifically interested in.
The free of charge CD-ROM is an exclusive service for ECA event attendees
GMP Certification Programme
Certainly one reason for the ECA's excellent reputation is its high-quality
Certification Programme. More than 730 GMP professionals already achieved the
ECA Certification Level within the GMP Certification Programme. And
professionals continue to rely on the programme to advance their knowledge and
to get an additional qualification. ECA currently offers the following
- ECA Certified Validation Manager
- ECA Certified Quality Assurance Manager - Pharmaceutical
- 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
Successful Courses / Conferences
In general, 2007 was a quite successful year with plenty of remarkable courses
and conferences. ECA also initiated a number of new education courses.
- For instance, "The Management of Clinical Trials - GMP
Meets GCP" covers all essential aspects relative to the organisation and
management of IMP supplies, their distribution and things to consider during
a study. The second edition of the course is scheduled for end of November.
(For more information on this course, please read the
GMP News from 22 October 2007)
- The second European GMP Conference confirmed the success of
the first conference in 2005. Last year the event drew close to 120
delegates who received an update on forthcoming authority activities from
both the European Medicines Agency (EMEA) as well as from the US Food & Drug
Administration. It is planned to conduct the conference every two years.
- Also conducted for the second time, the conference "Bio
Production Forum - Fill & Finish for Biopharmaceuticals" in Schaffhausen end
of November received a lot of attention. In addition to CILAG and the
University of Munich, who had already supported the first event in 2006, ECA
was able to win the Swiss Federal Institute of Technology and the Swiss
Society of Pharmaceutical Sciences (SSPhS) as supportive partners for the
ECA Working Programme 2008
In 2007, one of ECA's goals was to establish further cooperations with
appropriate partners in the industry to take advantage of their synergies. With
one of these identified partners, the Active Pharmaceutical Ingredients
Committee (APIC), the European Compliance Academy (ECA) signed a cooperation
agreement. Read the announcement about the cooperation between APIC and ECA for further information.
To identify further cooperation partners will also be part of ECA's planned
activities for 2008:
- Extension of strategic partnerships with other
organisations, interest groups and universities - expanding the network.
- Promotion of the free of charge multi user version of the
GMP Guideline Manager for ECA company members.
- To further establish/maintain contact with authorities the
ECA will consider developing conferences alike the GMP Conference with joint
- The ECA interest groups will continue to be active to
create more awareness. It is considered to present them at other events and
to get in touch with other organisations. Moreover, further subgroups are
planned to be established during the year.
The ECA is based on voluntary work of its members and Advisory Board members.
This will not change in 2008.
Advisory Board Members
The Advisory Board Members are: