Thomas J Pritchett, Ph.D., has worked with, among others, US, European, Canadian, and Latin American pharmaceutical, biopharmaceutical, and biologics companies, regulators, and institutes for more than 25 years, during which he has gained considerable experience in regulatory and technical aspects of Quality Assurance, Quality Control and CGMP Compliance for both investigational and marketed products. He is also an experienced teacher, and has been directing courses for leading training organizations since 1995. Notable training sessions Dr. Pritchett has recently provided include seminars and workshops for the US FDA, the NIH, and for regulators and industry professionals in the Gulf Cooperation Council (GCC). Dr. Pritchett is an active industry consultant, sits on the Editorial Advisory Board of BioProcess International, and is the co-founder/publisher of the newsletter BioQuality (www.bioquality.biz).