Biography
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC. 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. 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 serves as the Chair of the Excipient QbD/Composition Committee.
Research Interest
New Concepts for Drug Product Innovation & Novel Excipients - FDA Novel Excipient Pilot Program
Biography
Vladimir Matveevich Gruznov, Doctor of Sciences (Chromatography, Geophysics), Science Deputy Director of Trophimuk Institute of petroleum geology and geophysics Siberian Branch of Russian Academy of Sciences (Novosibirsk). Field of work: substance and elemental analysis for explosives detection, geophysics and ecological monitoring. Developed the concept for high-speed highly sensitive gas chromatography detection of EXPLOSIVES and chemical control of the environment. The concept is implemented in the portable devices of the world level. Publications: over 190 research papers including 3 monographs and 16 patents.
Research Interest
Substance and elemental analysis for explosives detection, geophysics and ecological monitoring
Biography
Gerhard Kratz has completed his studies at University of Applied Sciences in Berlin. His dissertation was about Planning, calculation and construction of a Fluidized bed reactor. Deepening during his studies was Water economy, chemical technology, plastic technology, varnish and paints, oil processing. First positions in industry were in pharmaceutical industry doing HPLC method development on various HPLC brands. Specialized in HPLC column selection and teaching customers in troubleshooting all over the world he is supporting several internet forums for HPLC questions. He is interested in troubleshooting.
Research Interest
HPLC Troubleshooting Analytics