E23-17: Practical LC-MS/MS Method Validation for Practical Scientists

One-Day Course
Tuesday, Nov. 14; 8:30am – 5:00pm

Dr. Perry G. Wang, LC-MS Technical Expert, Burtonsville, MD

This one-day short course will focus on LC-MS method validation for drugs, foods, dietary supplements, environmental, and cosmetics. It will help audiences to comply with the regulations for drug discovery and development in the pharmaceutical industry and other fields. The short course reflects the contents of the recently published guidance – bioanalytical method validation. It covers the basic validation concepts and step-by-step validation essences. After this course, the students should confidently apply the knowledge to validate their own methods. Learning objectives include:
– 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

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.

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

Dr. Perry G. Wang

has been a chemist at US FDA since 2008. Prior to joining the FDA,
he worked in the pharmaceutical and medical-device industry for more than 10 years. He received his Ph.D. from Oregon State University. He specializes in LC-MS method development and validation for drugs, cosmetics, foods, and dietary supplements. He has been invited to teach this course at ASMS since 2015. He teaches these courses in his own capacity as a scientist, but not as an employee of the FDA.