Tom Garcia is a Research Fellow in Global CMC, Pfizer Inc., Groton, Connecticut. He received a B.S. in Pharmacy from Albany College of Pharmacy in 1983, and a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1989. Prior to joining Global CMC in 2003, Tom spent over 14 years in the pharmaceutical industry in the areas of process development and technology transfer, where his primary interests were powder mixing, blend sampling, and the use of statistical techniques during process development, optimization, and in the assessment of process capability and robustness. He has been active in defining regulatory strategies for Quality by Design (QbD) dossiers. Tom has been an Adjunct Associate Professor in the Department of Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences since September 2011. He was also an Adjunct Associate Professor in Pharmaceutical Sciences at Campbell University (1996 – 2000), a member of the SUPAC IR Industry Training Committee (1995-1996), served as Chair of the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (2000-2004), was a member of the ISPE Product Quality Lifecycle Implementation Control Strategy Task Team (2007-2010), and leads the ISPE BUCU Group (2013-present).