Bikash Chatterjee Leads Workshop at Pharma IQ Conference in January.

Pharmatech President Offers Risk Management Techniques for Process Scale-Up

FOSTER CITY, Calif. -- Bikash Chatterjee, president of Pharmatech Associates, Inc., a leader in biopharma manufacturing process methodology, will present a workshop at the Pharma IQ conference on Process Scale-Up for Pharmaceutical and Biologics Development convening in Philadelphia on January 29-30, 2007.

Recognized internationally for his expertise with continuous process improvement applications such as Six Sigma and Lean in the regulated life sciences, the Chatterjee workshop will describe a scientific approach deploying risk management techniques to address the variables that affect overall product quality. The workshop will detail integrated characterization throughout the cycle of development to scale-up, and highlight how a risk management approach increases process predictability while reducing the cost of poor quality.

"New FDA guidance, outlined in the agency's movement to Process Analytical Technology (PAT), signals a profound shift from a product-centric approach based on inspection to one that is process-centric, based upon understanding and acting on the variables that affect product quality throughout all development phases," said Chatterjee. "This is the basis for a holistic treatment of the drug development cycle that Pharmatech Associates refers to as 'Compliance through Science.'"

Chatterjee, a Six Sigma Master Black Belt, has been involved in the life sciences industry for more than 20 years. He also has ISO 9000 Lead Assessor certification, as well as more than 15 years of experience in the implementation of Lean Manufacturing programs in the regulated life sciences. He was recently elected president of ASQ Golden Gate Chapter and was selected by United States Pharmacopeia (USP) as an advisor to its program to assist drug companies in applying GMP requirements internationally. Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego.

About Pharmatech Associates

Pharmatech Associates, Inc., based in the San Francisco Bay Area, is a full-service consultancy dedicated to serving the regulated life-sciences market, providing tailored project management, validation services and quality process optimization solutions that ensure optimal outcomes. Pharmatech Associates consulting services focus on cGMP readiness and Quality System development, and include product development guidance to negotiate the complexities of the product development life cycle on pharmaceutical, biotech and biopharma projects. Pharmatech is the national leader in applying Lean Manufacturing and Six Sigma processes to Biopharma manufacturing and production processes. For more information, please visit: www.pharmatechassociates.com.