Tom Garcia is a Research Fellow in Regulatory 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. He has been active in defining regulatory strategies for Quality by Design regulatory submissions. Prior to joining Regulatory CMC in 2003, Tom spent over 14 years in the pharmaceutical industry in the areas of process development and technology transfer. 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 currently an Adjunct Associate Professor in Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences, and held an adjunct faculty position at Campbell University from 1996 – 2000. Tom was a member of the SUPAC IR Industry Training Committee (1995-1996), and served as Chair of the PQRI Blend Uniformity Working Group (2000-2004).