President/Owner/Consultant & Vice Chair of IPEC-Americas QbD Committee
Black Diamond Regulatory Consulting/IPEC-Americas
Lansdale, Pennsylvania
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.
With over 44 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements.
Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. He was at Colorcon from 1977 until 2019.
Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee and is the Chair of the QbD/Composition Committee, where he is actively involved with the development of Regulatory, Safety, GMP and Supplier Qualification related guidelines to improve Excipient Quality and Safety.
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Monday, October 17, 2022
3:45 PM – 4:00 PM ET