About this Course:  Transitioning to recombinant cascade reagent (rCR) endotoxin testing requires proper validation to meet regulatory expectations. However, many labs still face challenges with study design, control selection, and interpreting results. Without a clear plan, validation efforts can become time-consuming and expose the lab to compliance risks. 

This short course provides a step-by-step guide to validating rCR product testing for Trillium vials. With expert insight and practical examples, labs will gain the knowledge to streamline the process and complete a successful validation.  

These trainings are provided as guidance for validating recombinant test methods and are Charles River’s suggested strategies. It is important to discuss the strategies with your local regulatory agency prior to submission to ensure all aspects of validation are covered.

Intended Audience:  Quality control professionals responsible for raw material, in-process, and final-release testing across a wide range of product types. These individuals support companies looking to improve efficiency, reduce testing timelines, and adopt more sustainable practices. 

Secondary Audience: This training is relevant for professionals working with pharmaceutical products, biologicals, nuclear medicine samples, dialysis fluids, pharmaceutical water systems, stem cell materials, cleaning validations, medical devices, and compounded preparations.