ECA establishes new Working Group - Invitation to get involved

Within the quality control environment there is quite a number of issues that have not been addressed adequately yet. These issues were partly discussed during the ECA Foundation Board Meeting in January 2010 - and the Board therefore decided to establish a new ECA Working Group on Analytical Quality Control.

It is the group's intention to generate more awareness for these issues. Therefore, a whole set of goals and objectives was defined:

  • Provision of a European wide networking platform for Analytical Chemist and Scientists working in and managing a Quality Control environment.
  • Promotion of active discussion of the latest regulatory requirements for Quality Control within the European Union and US.
  • Identification and addressing of technical issues and challenges within the Quality Control environment including training needs.
  • Active support for a harmonised approach to common problems and issues by the generation of discussion/position papers and generic procedures via expert working groups.
  • Facilitation of effective and efficient communication between industry, competent authorities and the pharmacopoeias.

As one of the first projects the new working group will concentrate on developing a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. To manage this project the steering committee is looking for ECA members interested in getting actively involved to set up a review team.

To find out more about the new working group and about its first project please see the Working Group's web presence and the first project information.

If you are interested in getting involved in the ECA review team please send your name, company and e-Mail adresss to analytic@gmp-compliance.org. All ECA Members are entitled to join the team.

Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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