The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results.
Version 2 of the ECA OOS SOP has already been available for all ECA members since 2013.
Given the complexity of the topic, it was decided that the handling of OOT and OOE results should be addressed in a separate guideline SOP, since there is both a lack of knowledge in the industry and a lack of guidance for trend analysis from the regulators in spite of increased regulatory interest in this area.
In 2013 the ECA’s QC Working Group decided to address these issues by developing a new guideline aimed at QC and other quality groups to encourage the application of a consistent and scientifically sound approach to trend analysis as part of a QMS for assuring data integrity.
From this foundation the current OOE/ OOT Laboratory Data Management Guidance was developed by an international team to provide a harmonised approach to trending.
At this ECA OOE/OOT Training Course version 01 of the OOE/ OT Laboratory Data Management Guidance will be presented and participants will have the opportunity to review and discuss the contents and technical aspects of the guidance document as well as looking at the scope and application of the proposed methods within industry.
This conference is intended for technical and managerial personnel dealing with out-of-trend or out-of expectation results, including R&D, production, analytical laboratories, contract laboratories, and Quality Assurance/Quality Control personnel.