Cindy Qin

Sr, Associate Director, Material and Analytical Science @Boehringer Ingelheim

Develop and validate methods for assay, impurities, solvents, cleaning verification of equipment, metals, counter-ions, GTIs etc. Purity, stability for API and other Test articles used in GLP studies Characterization of Reference Materials GMP controls for API Starting Material (APISM) and API Control Strategy for GTIs & metals, Specifications, Justification Memos, Test Procedures, Cleaning Verification, Reports, Sampling Plans Set up Stability Studies for Clinical and non-Clinical Stress stability studies for method development/validation/initial retest period ICH stability studies at long-term and accelerated storage conditions Formulation Analysis: NCE & NBE (exploratory tox and GLP studies) Formulation stability studies NDS antibody purity assessment IMPD/CTAA document preparations Nonclinical submission principal investigator subreports, GLP study protocols, and CoA documents