SC4: Bioanalytical Method Validation by LC-MS
SUNDAY, MAY 3 | 10:00 AM – 1:00 PM
ABOUT THIS COURSE:
This short course will focus on practical LC-MS method validation for small molecules in biological matrix. It will help audiences to comply with the regulations for drug discovery and development. This course will benefit the analytical chemists, lab
supervisors, QA/QC managers, regulators, and CRO consultants who work in the GLP-regulated labs and in the pharmaceutical industry. This course will also benefit all levels of management as a refresher course to stay current with the GLP regulations
and guidance.
WHAT YOU WILL LEARN:
- Why do we need to validate a method
- Full, partial and cross validation
- Validation requirements and challenges
- How to validate LC-MS methods for small molecules in biological matrix
- How to apply the validated methods for bioanalysis
- Case studies
COURSE AGENDA:
10:00 am Session I
- The role of the new guidance
- Requirements for reference standards and internal standards
- How to prepare standards and QC samples
- How to design an accuracy and precision run
- Batch acceptance criteria
- Stability validation: Stock solution, Autosampler, Benchtop, Freeze-thaw, Long-term storage
10:45 Coffee Break
11:00 Session II
- Recovery and extraction efficiency
- Matrix effects and carryover
- Evaluation of sensitivity, selectivity and specificity
- The use of a validated method for routine analysis
- Reassay and incurred sample reanalysis
- How to report re-assay results
12:45 Q&A
1:00 Close of Course
INSTRUCTOR BIOGRAPHY:
Perry Wang, PhD, Research Chemist, US Food and Drug Administration (FDA)
Dr. Perry G. Wang worked in the pharmaceutical and medical-device industry from 2000 to 2008. He received his Ph.D. degree at Oregon State University. Dr. Wang currently works at FDA as a chemist. In addition to over twenty peer-reviewed publications, he has edited and co-edited five books: "High-Throughput Analysis in the Pharmaceutical Industry", "Monolithic Chromatography and Its Modern Applications", "Hydrophilic Interaction Liquid Chromatography (HILIC) and Advanced Applications", "Counterfeit Medicines", and "High-Throughput Analysis for Food Safety". His expertise focuses on high throughput analysis and validation by LC-MS. He prepares and teaches this course in his own capacity but not as an employee of the FDA. He has been invited to teach this course at ASMS since 2015..