David M. Bliesner

DAVID M. BLIESNER, Ph.D., is Founder and President of Delphi Analytical Services, Inc. (Delphi). Delphi provides CGMP products and services to the Pharmaceutical, Biopharmaceutical, Contract Analytical Laboratory, Dietary Supplement, Compounding Pharmacy, and Allied Industries. Dr. Bliesner has a bachelor’s degree in chemistry from the United States Naval Academy, a doctorate in Analytical Chemistry from the University of Vermont, and an MBA from the School of Hard Knocks. He possesses a unique combination of science and business skills and experience. These skills and experiences range from analytical R&D in the pharmaceutical industry to business plan preparation and market analysis in the chromatography supplies and contract analytical and instrument services businesses. Dr. Bliesner’ s expertise includes quality assurance auditing of CGMP laboratories, developing and implementing corrective action plans for analytical laboratories with compliance challenges, high performance liquid chromatography, experimental protocol design, project management, and designing, building, staffing, and qualifying CGMP laboratories. Over twenty years he has been part of the “Expert Consultant” contingent for five (and counting) companies operating under consent decree with the FDA. During these consulting assignments he has conducted in-depth CGMP Laboratory Audits and developed and help execute Corrective and Preventive Acton Plans (CAPAs) to help organizations meet their commitments to FDA. Dr. Bliesner is also author of “Establishing a CGMP Laboratory Audit System: A Practical Guide”, “Validating Chromatographic Methods: A Practical Guide” and “Laboratory Control System Operations in a GMP Environment John Wiley & Sons, Inc. publishers.”