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Intellectual Property (Patent, Trademark, Copyright), Breach of Contract, & Royalty Audit Financial Damage Calculations
Economic Damages Expert Witness, Royalty Audit, Fraud, & Forensics Expert is experienced as an economic damages expert in State, Federal and USITC matters. In additional to economic damages and lost profits, Expert serves as an expert related to royalty audits…
Lyophilization
Expert's career in the pharmaceutical industry spans over 20 years. His work has focused on the following: • Supervision of pharmaceutical plants and technological transfers. • Development and implementation of operational standard procedures related to manufacturing processes and quality control.…
Organic Chemistry, Biocatalysis, Fermentation, Industrial Biotechnology, Chemical Process Development, Patent Liaison, Expert Witness for Patent Litigation
Expert has over 30 years of experience leading process development groups in a variety of fields. He employs biocatalysis and other biological methods to perform organic synthesis. In his current role, Expert offers executive-level technical strategy, project management, and due…
Pharmaceutical Formulation (Tablets, Capsules, Semi-solids, Liquids), QbD, and CMC Regulatory/Risk Assessment Issues
Expert is a Pharmaceutical Formulation Scientist with 25+ years' industry/FDA experience developing and commercializing tablets (fast dissolving, effervescent, chewable, coated), capsules, ODT's, coated beads (i.e., controlled release and taste-masked), topicals (liquids and semi-solids), & CBD/hemp products. He also has experience…
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Traffic Accident Reconstruction, Motorcycles, All-Terrain Vehicles ATVs/ROVs/UTVs, Industrial Accident Reconstruction, Amusement Ride Accidents, Product Defect and Failure Analyses
Expert has more than 15 years of experience providing forensic engineering services in motor vehicle crash reconstruction to law firms, public defenders and insurance companies; Automotive engineer; worked in the automotive industry for approximately nine years; Board certified Forensic Engineer…
Packaging Machinery, Manufacturing Efficiency, SMED, Changeover, OEE
Expert has over 35 years' experience working with the design, maintenance and operation of all types of packaging machinery, including flexible, filling, labeling, closing, cartoning and more. He is the author of the multiple books on packaging. He developed and…
Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…
Regulated and Hazardous Materials Auditing, Compliance, Programs, Processes and Training
Expert has utilized his scientific and logistics experience to analyze and consult regarding materials that were thought to be difficult or "impossible" to produce or ship in normal modes commerce. With an intimate knowledge of material and production processes he…
Flavors & Fragrances Operations Efficiency, Site Relocation / Consolidation, Quality, MES, Process Engineering
Expert has improved flavors manufacturing, flavors compounding and sample lab best practices across multiple international sites for a top multinational Fragrance and Flavors company. Expert applies this experience to evaluate facilities, develop and justify proposals to optimize and deploy practical…