National Costume: OOS Investigations Done Right From Compliance Pressure to Controlled Confidence

Friday, March 27, 2026

OOS Investigations Done Right From Compliance Pressure to Controlled Confidence

Greetings!

In a GMP regulated environment, Out of Specification (OOS) results are not just deviations to be addressed. They are signals that test the strength of your quality systems. Yet in practice, OOS investigations often become reactive, inconsistent, and documentation heavy exercises that leave teams uncertain rather than confident.

This workshop is designed to change that. Led by Kevin Mueller, Instructor at AAPS College with over 25 years of pharmaceutical industry experience across Novopharm Ltd. and Teva Canada Ltd., it is built for professionals working within laboratory, QA, and regulatory functions and provides a structured and practical approach to handling OOS investigations from initial identification to final reporting, with clarity at every stage. Participants will develop a working understanding of how to interpret Out of Trend (OOT) and OOS results, apply regulatory expectations, and execute Phase 1 investigations with precision.

The session also addresses critical decision points such as remeasurement, retesting, and resampling where compliance risks often arise. Equal emphasis is placed on what truly differentiates high performing teams, including documentation discipline, clear role accountability, and the ability to draw meaningful and defensible conclusions. Real world case studies and regulatory observations are integrated throughout to ensure alignment with actual industry expectations.

By the end of the workshop, you will not only understand how to investigate OOS results but also how to do so in a way that is consistent, audit ready, and aligned with global regulatory standards. This session is particularly relevant for quality assurance professionals, regulatory affairs specialists, laboratory analysts, and supervisors responsible for maintaining compliance and product quality within GMP environments.

All participants will receive a certificate of attendance along with a comprehensive course manual designed for ongoing reference.

Get 20% off with early bird pricing by using code SAVE20 and registering by April 3. If OOS investigations are part of your responsibility, this is not just another training. It is a shift towards controlled, confident, and defensible quality practices.