Bikash Chatterjee, is President and Chief Technology officer of Pharmatech Associates Inc. a full service consulting firm specializing in assisting clients with the development of new drug products, Operational Excellence education/implementation and deployment of operational and quality systems in the US, Europe, Japan and Asia. He has been involved in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years. He has guided the successful approval of over a dozen new products within the U.S. and Europe and is a frequent speaker at industry and regulatory events around the world. He has published and is a regular editorial contributor to several internationally recognized industry journals. Chatterjee has spoken and published extensively on the application of Quality Systems, P.A.T., Lean Six Sigma and Risk Management approaches within the regulated life sciences industry. He is an ISO 9000 certified Lead Assessor and Six Sigma and Lean Master Black Belt. His expertise includes emerging technologies including nanotechnology, MEMs and similar novel drug delivery platforms. Chatterjee is a member of the USP National Advisory Board and the Life Sciences IT Technical Advisory Board. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.