Data Quality Management of Aberrant Results – Handling Out of Specification, OOS, and Out of Trend, OOT results

PharmaLab Pre-Conference Event on 23 November 2026

Objectives

This pre-conference workshop aims to strengthen participants’ capability to manage data quality and investigate aberrant results in
pharmaceutical laboratories by:

  • providing a structured approach to handling Out of Specification (OOS) and Out of Trend (OOT) results,
  • explaining key regulatory and guidance expectations and how they translate into practical lab procedures,
  • applying trend analysis tools and statistical rules to evaluate OOT signals – incl. understanding common pitfalls and misinterpretations – through an interactive Excel-based exercise.

Target Audience

  • Laboratory managers, supervisors and analysts,
  • Quality control managers,Heads of quality control,
  • Qualified Persons (QPs),
  • Analytical scientists,
  • Senior laboratory staff,
  • Responsible authorities,
  • Service providers (contract research organisations and contract manufacturers).

Register now

Moderators

Dr Christopher Burgess, Chairman ECA Analytical Quality Control Group