Meet the AQCG Board Members at PharmaLab 2026

PharmaLab 2026 will take place on 24 and 25 November at the new venue, the Darmstadt Congress Centre, the 'darmstadtium' - accompanied by the new and expanded exhibition featuring suppliers and service providers from the fields of analytics, microbiology, contract research, and contract development and manufacturing. With one- or two-day tickets, you can attend all presentations on the main conference days and switch between conferences on that day. Pre- and post-events can be booked as optional extras.

This year, the ECA Analytical Quality Control Group (AQCG) will organise one of the pre-conference workshops and a dedicated one-day conference track.

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

The pre-conference workshop on 23 November aims to strengthen participants' ability to manage data quality and investigate aberrant results in pharmaceutical laboratories. It will provide a structured approach to handling OOS and OOT results, explain key regulatory and guidance expectations and show how these can be translated into practical laboratory procedures.

In addition, participants will apply trend analysis tools and statistical rules to evaluate OOT signals through an interactive Excel-based exercise, which will also address common pitfalls and misinterpretations. The pre-conference workshop will further cover specific challenges associated with the analysis of small molecules and biopharmaceuticals.

Analytical Procedure Lifecycle Management (APLM)

The dedicated one-day track on 24 November will provide a lifecycle-based and risk-driven framework for developing, validating and maintaining analytical procedures from early development through registration and post-approval change management. Participants will learn how to apply current USP developments and practical case studies covering analytical target profiles, risk assessment, the method operable design region, validation strategies, precision and replication, platform methods and ongoing procedure performance verification.

The track will address ICH Q2(R2), ICH Q14 and USP <1221>. The aim is to help participants define a fit-for-purpose validation scope, ensure method robustness and independence, and manage changes in an inspection-ready and dossier-ready manner.