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David SchonekerDirector of Global Regulatory AffairsColorcon, Inc

David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and raw material assessments.

He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977.

Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).

Mr. Schoneker is the past Chairman of IPEC Americas (2007-2008) and is the current Vice Chair for Science and Regulatory Policy where he is actively involved with the development of Excipient Quality by Design, Safety, GMP and Supplier Qualification related guidelines to improve Global Supply Chain Security, Drug Product Development and Excipient Quality.

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