FDA Experts

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FDA Devices

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Expertise Description: Ph.D. - More than 24 years of experience as a laboratory director, auditor, quality / regulatory expert in pharmaceutical / medical devices, and consumer product expert. Laboratory expertise includes product development, analytical chemistry, organic chemistry, inorganic chemistry, wet chemistry, laboratory testing, environmental sample testing, materials testing, complaint investigations, and preventative actions. Extensive experience in manufacturing, quality, and facilities system audits. Also familiar with US-FDA / EMEA issues, warning letters, remediation... » Read Complete Profile
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Expertise Description: Ph.D. – Consulting expert in Food Science with more than 35 years experience in the field. Expertise includes: control of E. coli O157:H7 in raw ground beef and other processed beef products; control of salmonella in various food products; and Listeria monocytogenes in processed meats. Additional experience in USDA and FDA food regulations and in the design and implementation of food safety systems, including HACCP. Ph.D. in Food Science. Over... » Read Complete Profile
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Expertise Description: M.D. – Consulting expert with over 40 years experience in Rheumatology / Allergy and Clinical Immunology. Chief of Rheumatology and university distinguished professor of medicine. Also specializes in internal medicine. Expertise includes environmental health, including food, safety, mold, and allergens. Clinical interests also consist of autoimmunity and nutrition / immunity. Has authored textbooks on allergy / immunology, autoimmunity, and nutrition / health. Has worked with governmental non-profit organizations and has... » Read Complete Profile
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Expertise Description: Pharmaceutical expert with more than 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries. Has extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. Experience includes various technical management positions in Quality Control, Technical Service, and as a Director of Research and Development in Pharmaceutical Packaging. Additional experience as an adjunct instructor at various area colleges, teaching Physical Chemistry, Finance, and Marketing. Has authored... » Read Complete Profile
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Expertise Description: R.N., C.L.N.C., C.P.S.S. – Consulting expert with more than 20 years experience in the field of Clinical Nursing and Medical Devices. Diverse experience with medical devices, including sales, education, training, equipment use, and product safety specialization. Extensive knowledge and consultation in the Emergency / Trauma, Urgent Care, and Operating Room. Served in both clinical and sales roles for Hemodialysis, Wound, Pulmonary, and Bariatric Medical Device Companies. Substantial experience in the... » Read Complete Profile
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Expertise Description: C.C.E. - Over 30 years experience in clinical applications and medical equipment and devices support. Areas of expertise include investigation of patient injuries involving medical equipment and devices... » Read Complete Profile
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Expertise Description: Consulting expert specialized in computers, technology, and intellectual property with more than 30 years experience in the fields. In 1993, founded and developed a knowledgebase of intellectual property that integrated channels on patents, litigation, reexaminations, claim constructions, FDA Orange Book technical standards, and pools. Consultant to many organizations on software development, internationalization, and product marketing strategy. Also experienced consulting on custom software development and project planning with particular expertise in... » Read Complete Profile
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Expertise Description: M.D. – Consulting expert in Bio-medical Engineering with more than 15 years experience in the field. Expertise includes medical devices, medical implants, surgical implants, surgical devices, biomechanics, orthopedics, biomaterials, biochemistry, implants, devices, quality control, FDA approval, failure analysis, immunology, and laboratory safety. Prior expert witness experience... » Read Complete Profile

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