ECA's 4th Annual Review (2002)

Annual Review 2002

Number of Members
The number of members of the European Compliance Academy (ECA) increased also in 2002. Currently, ECA has 2,539 members from 39 countries. This is an increase of 10.6%.

CD-ROM "GMP Navigator" 5.0

Due to the large demand for the previous version, new development steps have been realised in version 5.0. A new user interface makes it much easier to navigate through the documents. By means of compressing the Warning Letter files, the number of documents on the CD could be raised significantly. A new feature are the documents of the Global Harmonisation Task Force (GHTF). As in the past years, the CDs are exclusively given free of charge to the participants of ECA events.

1-year Review of the Professional Certification Programme

The Professional Certification Programme enables interested persons to acquire the following certificates:

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

Many of the participants make use of the opportunity to take part in this ECA Certification by attending 3 events. We are happy about the good response! Therefore, the Programme will be extended considerably in 2003.

Web Service www.gmp-compliance.org

The number of visitors increases every month. At an average, more than 2,000 ECA members and non-members visit the website monthly. After the installation of the Meta Search as a tool that can be used by all visitors, a new service will soon be offered exclusively to ECA members (in the Members Area). The new service, called "Guideline Tree," will be available from May to June to all visitors. After 15 June, this service will only be accesible to ECA Members.

Educational Programme

In 2003, we intend to augment the number of ECA events from 33 in 2002 to 47. Last year's trend to offer high-quality Education Courses will be continued. It is our aim to offer seminars with a limit to the number of participants, however, not to have them conducted by one or two consultants, as is common practice. Regarding these intensive seminars, we rather arrange for the lectures to be given by several speakers from industry, authorities and service industries.

ECA Working Programme 2003 and 2004

Also in the future, ECA will 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 carry on offering all of the services free of charge to our members.

Advisory Board Members

Also in 2002, we were able to extend the ECA activities through the work of our Advisory Board with members from the industry, associations and authorities. The Advisory Board members are:

Active pharmaceutical ingredients	Dr N. Franklin, Interactive Consulting, Germany
Active pharmaceutical ingredients	Matt Moran, IPCMF, Ireland
Computer validation (incl. Part 11)	Dr W. Schumacher, F. Hoffmann-La Roche, Switzerland
GMP supervision	Rudolf Völler, Regierungspräsidium Darmstadt, Germany
GMP supervision	John Taylor, MCA, UK
Analytical quality control	Dr Ludwig Huber, Agilent Technologies, Germany
Analytical quality control	Dr Bernd Renger, Baxter AG, Austria
Microbiological quality control	Mike Edgington, MicroSafe B.V., Netherlands
Quality Assurance	Dick Bonner, Eli Lilly, UK
Regulatory Affairs	Dr Boris Pimentel, Roche Vitamins, Switzerland
FDA Compliance	Daniel Scheidegger, Genzyme Pharmaceuticals, Switzerland

Author: Dr Peter Reichelt Chairman, European Compliance Academy