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Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Food Safety and Quality
Expert is a professional food safety consultant and auditor who has been registered with SQF (the Safe Quality Food Institute) as such. He has accrued vast experience implementing food safety and quality assurance compliance systems for top-tier food manufacturing firms.…
Expert in FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Expert in Feed Industry Consultant: Animal Drug & Feed Laws, regulations, registrations, approvals, compliance
Expert has 45 years of experience in Animal Drug and Feed regulatory and Quality Issues. He has worked as Director of Regulatory and Quality for Purina Mills for 35 years. Expert has served as an expert witness is many various…
Expert in 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…
Expert in 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…
Expert in Nutrition Labeling Laws and FDA Regulations, Nutritional Genomics, Disease Prevention, DHA
Expert has been a researcher, consultant and teacher of nutrition at some of the most prestigious medical institutions in the country. She is the Director of the Nutrition Information Center. Her research focus currently centers on the nutritional interactions between…
Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence
Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…
Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…
Expert in Medical Device Design Control and Software Validation
Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…