November 14 2019 OMB Meeting Materials

AOAC OMB MEETING MATERIALS

107

Eurofins Central Analytical Laboratories 2219 Lakeshore Drive, Suite 500, New Orleans, LA 70122 (504) 297-3400 Toll Free: (866) 388-3400 Fax: (504) 297-3410

Cheryl D. Stephenson, Ph.D. Laboratory Director Test Facility / Test Site Management Designee Career analytical chemist with over 20 years of industry experience, ranging from bench analytical researcher to R&D group leader, quality lead, laboratory strategy and operations lead, production laboratory supervisor and current role as laboratory director. Versed in all areas of analytical chemistry as applied to polymer and agricultural chemicals manufacturing, biotechnology and food and feed quality testing. Experience applying modern analytical chemistry techniques, including laser excited atomic fluorescence, fluorescence emission spectroscopy, UV-Vis absorption spectroscopy, infrared spectroscopy, near infrared spectroscopy, inductively coupled plasma (ICP) – atomic emission spectrometer, ICP-mass spectrometry, gas chromatography with flame ionization detection and with mass spectrometric detection, high performance liquid chromatography with fluorescence and UV detection. Extensive experience in analytical quantification using liquid chromatography with triple quadrupole mass spectrometry (LC-MS/MS) and gas chromatography with single and triple quadrupole mass spectrometry (GC-MS and GC-MS/MS) for the food quality testing industry. Also knowledgeable in various wet chemical methods, such as titrimetric methods, moisture and protein analyses. Laboratory Director • Responsible for oversight of the daily technical operation of the laboratory. • Responsible for directing activities and setting policies, procedures, and guidelines for the quality system, and technical practices. • Ensuring laboratory compliance with the ISO/IEC 17025 (2005). • Ensuring laboratory compliance with the cGMP and cGLP regulations 21 CFR 11,110, 111, 210, 211, 225 and 226 • Testing facility management designee for studies/projects performed under GLP quality standards. Test Facility / Test Site Management Designee Testing facility / Test Site management designee/delegate under GLP quality standards: • Designate a study director as described in 58.33, before the study is initiated. • Replace the study director promptly if it becomes necessary to do so during the conduct of a study. • Assure that there is a quality assurance unit as described in 21CFR Section 58.35. • Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. EXPERIENCE Eurofins Central Analytical Laboratories, New Orleans, LA 2013-Present

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