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Expertise Description

I have 25 years of experience in the Pharmaceuticals and Medical Device Industry. My experience as a Laboratory Director includes product development, analytical chemistry, organic chemistry, inorganic chemistry, wet chemistry, laboratory testing, environmental sample testing, materials testing, complaint investigations, FDA investigations, quality assurance, manufacturing, facilities system audits, preventative actions, US-FDA / EMEA issues, warning letters, remediation, Therapeutic Goods Administration (TGA) inspection, Millennium Challenge Corporation (MCC) inspection, analytical method development, method validation, internal and external laboratory audits, optimized equipment usage, use of developmental software, consumer products, extensive knowledge in active pharmaceutical ingredient (API) synthesis, active pharmaceutical ingredient (API) and dosage form analysis, stability programs, non-conformance investigations, quality engineering, process optimization, laboratory training, stability study protocols, and pharmaceutical lawsuits. I have prior expert witness experience.

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Expert Witness

My expert witness experience includes: lawsuits regarding pharmaceuticals.


Consulting Experience

My consulting experience includes: Specialized consultations regarding compliance audits, monitoring, GMP training, preparation of drug master file (DMF), and stability studies; Implemented quality systems, developed and established solvent recovery capabilities for manufacturing; Planned / directed development and technical customer support for industrial fabric washing, kitchen hygiene, and food and beverage hygiene; Process development and pilot plant studies of pharmaceutical and agrochemical products.


Professional Experiences




Education

DegreeSubjectInstitution
Ph.D.Organic ChemistryIndiana University
M.A.Organic ChemistryRice University

Licenses Certifications

Awards & Affiliation

Primary Affiliation

American Chemical Society (ACS)


Partial List of Consulting Expert Witness Cases