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

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.

Highlights

• Regulatory expectations and & guidance for OOS/OOT: how to stay compliant
• Hands-on evaluation: trend analysis tools + interactive Excel workshop
• OOS for small molecules and in biopharmaceutical analysis: specific challenges, examples, and best practices

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).