Quality Control Expert Witnesses

Port Saint Lucie, Florida

Laboratories & Testing, Pathology - Clinical laboratory, Clinical laboratories, Quality assurance, Regulatory compliance, Accuracy, SOPs, Protocols, Toxicology, LCMS, LCMS-MS, Drugs of abuse, PCR, RT-PCR, Vendor disputes, Implementation, Quality control, CLIA, COLA, CAP, ISO 17025

Attorney references available upon request. CLINICAL LABORATORY DISPUTES – Urine drug testing — immunoassay & confirmatory methodology – False positives/negatives; confirmation testing standards – CLIA & CAP regulatory compliance & violations – Lab director standard of care & certifying scientist duties – QA/QC documentation, chain of custody, specimen validity – PCR assays: UTI, respiratory pathogens, antibiotic resistance CANNABIS LABORATORY DISPUTES – Expert opinion on ISO 17025 compliance, citation defense & accreditation standards – Cannabis lab practices, SOP adequacy, risk identification, & corrective action BACKGROUND – Ph.D., Columbia University (2016) — Cellular, Molecular & Biomedical Studies – Clinical Laboratory Director since 2021; currently directing multiple CLIA-certified labs – Supervisory experience: lab installation, validation, QC/QA, and staff oversight – Published researcher; peer-reviewed scientific publications

Conyers, Georgia

Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components

Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.

Nashua, New Hampshire

Metallurgy, Failure Analysis - Design Defects, Material Selection, Engineering, Manufacturing Defects, Manufacturing, Quality Control, Mechanical Failure, Corrosion, Fitness for Use, Equipment Operation, Equipment Maintenance, Trade Secrets

Testifying and consulting expert for both plaintiff and defense counsel. Cases have involved hand tools, recreational and exercise equipment, fire fighting apparatus, rotating machinery, construction hardware, fasteners, joints, piping, tubing, lighting fixtures. 40+ yrs designing, manufacturing and quality assurance of components for consumer & industrial products including safety and performance-critical applications for aircraft, automotive safety systems, medical products, construction machinery, defense arms and munitions. Mr. Caldwell has testified in patent infringement and trade secret misappropriation cases. He has lectured in the USA, Europe and India on manufacturing premium quality metal products. He has published in the areas of batteries, materials selection and materials processing. Licensed Professional Engineer, Ohio. US Patent holder.