Leaders of our Raw Materials department, Heather Ludwig and James Joslin, provide an overview of the USP/NF procedure for residual solvents determination. In this presentation, they will review our own approach for residual solvents testing, including requirements for verification and validation. They also offer an overview of the submission process, including advice to determine when a verification and/or validation is required.
Key Learning Objectives:
Overview of USP/NF <467> Residual Solvents and <1467> Residual Solvents – Verification of Compendial Procedures and Validation of Alternative Procedures testing procedures
Learn Pace® procedure for executing USP/NF Residual Solvent testing
Heather Ludwig, PLS Associate Director - Raw Materials, Pace® Life Sciences – Oakdale
James Joslin, PLS Group Leader - Raw Materials, Pace® Life Sciences – Oakdale