Live Online Training: Handling OOS Results

This Live Online Training provides practical advice on how to deal with OOS Results. You will get to know the European Regulatory Expectations and what FDA and European guidelines tell us about handling OOS Results. During the training the following aspects will be covered:

Participants will get OOS case studies upfront. During the training options how to deal with the results will be discussed and possible solutions will be suggested.

Since the often cited Barr ruling (Wolin Judgement) of February 1993 pharmaceutical companies all around the world have implemented procedures and strategies on how to deal with results that do not comply with their predetermined specifications. Although 27(!) years have passed since that judgement and although in the meantime FDA and MHRA have published guidances about OOSs, the investigation of OOS results continues to be a hot topic in FDA inspections. The incorrect handling and investigation of OOS results is still frequently cited in Warning Letters.

The ECA Working Group on Analytical Quality Control decided to address these aspects and developed a harmonised guideline SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results. It encourages the application of  a consistent and scientifically sound approach to trend analysis as part of a QMS. The current Version 2 is available for all ECA members on the ECA members area.