David Schoneker Colorcon

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David Schoneker Colorcon

David R. Schoneker is the Director of Global Regulatory Affairs at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets.

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 Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).

Mr. Schoneker was the Chairman of IPEC Americas during the period 2007-2009. He is now serving as the Vice Chair of Maker and Distributor Relations where he is actively involved with the development of Excipient GMP and Supplier Qualification related guidelines to improve Global Supply Chain Security. He also Co-Chairs IPEC’s QbD/Product Development Committee and Composition Committee and is a member of the Board of Directors of the IPEC Foundation.

He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization. He previously was the USP Liaison for IPEC Americas and represented them as a member of the United States Pharmacopeial Convention. Mr. Schoneker previously coordinated International Harmonization efforts for the IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients. He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis. Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients.

Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 2nd edition of the Enclyclopedia of Pharmaceutical Technology which was published in 2002. He has also authored a number of other excipient quality and safety relatd papers in various journals and trade magazines.