The rCR Validation Training Your QC Team Has Been Waiting For
QC teams routinely hesitate to adopt recombinant endotoxin testing methods despite clear regulatory support for these approaches. They face uncertainty about validation expectations and lack structured implementation guidance. Charles River’s four-part video series provides the confidence laboratories need to move forward, translating regulatory requirements into practical validation plans that cover study design, control selection, acceptance criteria, and implementation across Endosafe® Trillium™ recombinant cascade reagent (rCR) applications.
What Each Module Covers
- Module 1: Product Approach (Trillium Cartridges) Map regulatory expectations to cartridge-based product workflows. Build a study design with appropriate controls and acceptance criteria. Plan and interpret interference testing.
- Module 2: Product Approach (Trillium Vials) Translate the product approach to vial workflows without losing rigor. Handle borderline results with a predefined decision path.
- Module 3: Water Approach (Trillium Cartridges) Address water-specific considerations in cartridge testing. Define acceptance criteria tied to water matrices and roll out the method.
- Module 4: Water Approach (Trillium Vials) Adapt the water approach to vial formats. Identify and mitigate potential interferences early.
One registration provides access to all four modules. Teams choose the path that matches their testing environment and move forward with a validation approach backed by expert guidance and built on the same science that supports Trillium's demonstrated equivalency to Limulus amebocyte lysate (LAL). The transition to rCR is not a question of if, and this training ensures the lab is prepared when the time comes.
Fill out the form to access the full training library.
Frequently Asked Questions
-
Is this training product or water-specific?
Both. The library covers product and water approaches, each for Trillium vials and cartridges.
-
What is covered in these videos?
A practical validation plan covering regulatory expectations, study design, control selection, acceptance criteria, interference testing, and implementation strategies, tailored by matrix and format.
-
Does this guarantee regulatory approval?
No. The training aims to align your validation with regulatory expectations and good practice. Regulatory outcomes depend on your application, data, and context.
-
Is there a difference between the vial and cartridge approaches?
The core validation principles are consistent, but the trainings highlight format-specific considerations for vials vs. cartridges within each matrix.