Dave Schoneker Email and Phone Number
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I am experienced in many areas related to regulatory affairs and quality assurance for pharmacuetical excipients, non-dietary ingredients for dietary supplements, food additives and color additives. I have over 42 years in the excipient and food/color additive industry where I have been involved in many formulation and problem-solving projects related to solid oral dosage forms. I am heavily involved in many trade associations where I have been successful in helping to shape excipient, food additive and colorant regulations and guidance around the world. I am the President/Owner/Consultant of my own regulatory/quality consulting firm called Black Diamond Regulatory Consulting, LLC and I can work with companies or other parties who may have difficult regulatory or quality problems to solve or who need regulatory, quality, auditing or training services.
Temple University School Of Pharmacy
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Adjunct Professor In Graduate Ra And Qa ProgramTemple University School Of PharmacyPhiladelphia, Pa, Us
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Adjunct Professor In Graduate Ra/Qa ProgramTemple University School Of Pharmacy Jan 2020 - PresentPhiladelphia, Pennsylvania, UsTeaching the following courses as part of the RA/QA Master's program:- Regulation of Dietary Supplements and Functional Foods - Spring- Global Excipient Regulations - FallThese are Online courses so they can be taken by anyone anywhere who is part of the RA/QA program. -
President/OwnerBlack Diamond Regulatory Consulting, Llc Sep 2019 - PresentDavid 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/color additive regulatory, quality and supply chain concerns.
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Vice Chair For Science And Regulatory PolicyIpec-Americas Jan 2017 - PresentArlington, Va, UsIn this role, I coordinate many science and regulatory projects for IPEC-Americas and act as a key point of contact with the U.S. FDA, USP and many other regulatory agencies and pharmacopoeias around the world. -
Board MemberIpec Foundation 2006 - PresentThe IPEC Foundation provides awards, scholarships, etc. to people who have significantly enhanced the development, safety and use of pharmaceutical excipients through research or industrial applications.
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PresidentInternational Association Of Color Manufacturers Inc (Iacm) Dec 2018 - Aug 2019
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Global Regulatory Director - Strategic RelationshipsColorcon Jul 1977 - Aug 2019Harleysville, Pa, UsCoordinated all of Colorcon's Regulatory activities around the world. Prior to 1995 I was the Director of Quality Assurance and Quality Control where I managed the Quality Control laboratories, developed and implemented Colorcon's Quality Policies and Guidelines and led Colorcon's supplier qualification program. I was involved in many trade and professional organizations related to the manufacture and use of pharmaceutical excipients and food/color additives. -
Colorcon ColleagueColorcon 2000 - 2008Harleysville, Pa, Us
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Vice Chair For Maker And Distributor RelationsIpec-Americas 2012 - 2015Arlington, Va, UsIn this role I coordinate various activities related to interests of pharmaceutical excipient makers and distributors and also act as a liason with many other related pharmaceutical or food trade associations such as IFAC, IACM, CRN, CHPA, GPhA to discuss issues of mutual concerns. I also get involved in forming various Coalitions on hot topics where the industry needs to come together on an issue with one voice to regulators, pharmacopeias or othe government officials.
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Convention DelegateUnited States Pharmacopeia 1995 - 2010
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Past ChairmanIpec Americas 2007 - 2009Arlington, Va, Us
Dave Schoneker Skills
Dave Schoneker Education Details
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Villanova UniversityAnalytical Chemistry -
Ursinus CollegeChemistry
Frequently Asked Questions about Dave Schoneker
What company does Dave Schoneker work for?
Dave Schoneker works for Temple University School Of Pharmacy
What is Dave Schoneker's role at the current company?
Dave Schoneker's current role is Adjunct Professor in Graduate RA and QA Program.
What is Dave Schoneker's email address?
Dave Schoneker's email address is ds****@****con.com
What is Dave Schoneker's direct phone number?
Dave Schoneker's direct phone number is +126725*****
What schools did Dave Schoneker attend?
Dave Schoneker attended Villanova University, Ursinus College.
What are some of Dave Schoneker's interests?
Dave Schoneker has interest in Traveling, Corvettes, Skiing, Golfing.
What skills is Dave Schoneker known for?
Dave Schoneker has skills like Regulatory Affairs, Pharmaceutical Industry, Pharmaceutics, Gmp, Fda, Technology Transfer, Formulation, Validation, Regulatory Submissions, Sop, Quality System, Quality Assurance.
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