E20-17: Practical LC-MS Method Validation

Thursday, Nov. 5 – Friday, Nov. 6; 10:00am – 2:30pm

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

Validating an analytical method ensures that the data are reliable by addressing certain key questions of the method, such as accuracy, precision, selectivity, stability, recovery and matrix effects. This course is practice-oriented on validation of analytical methods using LC-MS. It will help audiences to comply with the regulations for drug discovery and development in the pharmaceutical industry and other analytical fields. The short course will also reflect the recently published white papers with regard to bioanalytical method validation using LC-MS.

This one-day course will benefit the analytical chemists, lab supervisors, QA/QC managers, regulators, GLP auditors and CRO consultants who work in the pharmaceutical industry and other analytical fields. This course will also benefit all levels of management as a refresher course to stay current with the updated regulations.

  1. Validation Concepts
    a. Accuracy
    b. Precision
    c. Calibration curves
    d. External or internal standard
    e. Full validation, partial validation and cross validation
  2. Validation Essences and Acceptance Criteria<
    a. Preparation of stock solution
    b. Linearity and weighting factors
    c. LOD and LOQ discussion
    d. LLOQ and ULOQ
    e. Selectivity and specificity
    f. Stability
    g. Dilution integrity
    h. Recovery and extraction efficiency
    i. Matrix effects
  3. Application the Validated Methods for Study Samples
    a. How to design a batch or a run
    b. Incurred sample reassay
    c. Peak integration
    d. How to evaluate unknown study samples
    e. How to report multiple assay results
    f. Case studies

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.