ECA's 9th Annual Review (2007)

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.

Publications

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 and members.

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 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.

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 event.

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 industry/agency sessions/workshops.
• 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: