In the pharmaceutical industry, quality, safety, and efficacy are absolute requirements. Nevertheless, it is not uncommon for test results to fall outside of predefined specifications (OOS – Out Of Specification), deviate from expected trends (OOT – Out Of Trend), or exhibit unexpected behavior while still remaining within specifications (OOE – Out Of Expectation).
Such deviations may indicate underlying quality issues and demand a thorough, structured, and well-substantiated approach.
This one-day training offers an in-depth, practice-oriented overview of how OOS, OOT, and OOE results should be correctly identified, investigated, documented, and followed up on, in accordance with the expectations of authorities such as the IGJ, EMA, U.S. FDA, and MHRA. Through regulatory references, guidance documents, and real-life examples, you will learn how to manage OOS and OOT laboratory results effectively within your organization.
The training includes interactive elements such as workshops, group discussions, and case studies based on real OOS reports. As a result, participants gain not only theoretical understanding but also practical insight for application in their daily work.
