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FDA Consultant Expert Witness

Keywords

FDA Consultant, Food, Pharmaceutical Drugs, Cosmetic Industries, Regulatory Affairs, Labeling, Quality Assurance, Control, Product Development, Supplements

Arizona

Expert Witness No.271

Arizona

Experience

Self-Owned Consulting Company (established 1986)
Provides consulting and information services to the food, pharmaceutical, and dietary supplement industries in the areas of regulatory affairs, labeling, quality assurance & control, and product development.

Vita-Fresh Vitamin Company, Inc. (1985-1986)
Vice President of Science & Technology for major manufacturer of vitamin supplements & OTC drugs.  Reformulated major product line for enhanced sales appeal and 6-figure annual manufacturing cost saving.  Created product and raw material specifications and revised operating manual and drug master file.

Wm. T. Thompson Company (1977-1985)
Technical Director.  Responsible for regulatory affairs, product development, and QA & QC for this manufacturer of nutritional supplements & OTC products.  Ensured compliance of formulations, labeling, advertising, sales and technical literature with appropriate laws and regulations of federal and state authorities.

Abbott Laboratories, Diagnostics Division (1972-1977)
QA/QC for manufacturer of in vitro diagnostic reagents.  Analytical methods development, stability, operating procedures, GMP audits, etc.

Education

B.S. Chemistry, Stanford University 1966.  Independent research on preparative ruthenium chemistry with Professor Henry Taube, 1983 Nobel laureate.

Ph.D. Inorganic Chemistry, Penn. State University 1972.

Member

American Chemical Society
American Association of Pharmaceutical Scientists
Founding Member and Director, Western Vitamin Roundtable


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