Bioanalytical Method Validation by LC-MS/MS

Introduce the guidance and requirements for bioanalytical method validation Explain the importance of method validation for regulatory studies Learn how to design and validate an LC-MS method Discuss how to deal with the challenges to validate an LC-MS method Describe how to apply a validated method for regulatory samples

When and how to conduct a full, partial, and cross validation How to define and evaluate LLOQ and ULOQ How to evaluate precision and accuracy for QCs How to evaluate precision and accuracy for calibration curves How to select weighting factors How to validate specificity, selectivity, sensitivity and dilution How to validate matrix effect and extraction recovery How to validate long-term storage stability, freeze-thaw stability, autosampler stability, stock solution stability and bench-top stability How to write a validation report How to apply the validated method for routine analysis How to design an analytical run/batch How to accept or reject a run or a batch How to perform a reassay How to report analytical results What is the difference between pre-clinical studies and clinical studies

This short course will benefit all analytical chemists who use LC-MS in regulated labs, lab supervisors, QA managers and personnel, GLP auditors and CRO consultants, who need a fundamental understanding of regulations. This course is also beneficial to all levels of management as a refresher to stay current with the recently published guidance.