Yanhui Hu, Ph.D., works for AbbVie, a global biopharmaceutical company, which was formerly the pharmaceutical division of Abbott Laboratories. She is currently a Quality Assurance Project Manager in Operations. Dr. Hu holds a M.S. in Statistics and a Ph.D. in Chemical Engineering. She joined Abbott in 2002 and has held various positions in the R&D, operations and quality organizations. Hu has extensive experience in late stage API and DP development and commercialization, as well as establishing quality systems to support implementation of science and risk based approaches to product lifecycle. Dr. Hu is currently on the ISPE Process Validation development team and was one of the authors on the Process Validation discussion paper.