In the ECA OOS Workshop the following topics will be discussed:
- OOS: US/FDA Guidelines and European Regulatory Expectations
- OOS Results in R&D Laboratories
- Strategies not to generate OOS results
The current version of the OOE/OOT 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.