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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…
Safety (falls, heavy equipment, cranes) and Industrial Hygiene (toxic exposure)
Expert L. Expert was first certified as an IH in 1979 while with OSHA. Spent 8 years with OSHA and field directed IH and safety investigations in Nebraska, Iowa and Texas. Primarily area: Refineries and Chemical facilities in the Houston…
Cosmetic Manufacturing
• Successfully Handled a new range of Ayurvedic Manufacturing Factory from the scratch. Efficiently Managed a Factory with 400 man power. • Managed Five 3rd party manufacturing plants successfully. • Successfully Handled Flavour & Perfume Blending unit. • Setting up…
Sourcing / Procurement / SCM Functions
Expert is a seasoned Procurement / SCM professional with over 30 years of industry experience with a reputed diversified group of companies. He has been heading Procurement / Sourcing / SCM functions in a complex business environment for 23 years…
Consumer Product Safety, Regulatory and Retail Compliance, Quality Assurance
Expert is a consumer product (non-food) safety, regulatory and retail compliance, quality assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local compliance…
Toxicologist, Dietary Supplement and Functional Food compliance
Experienced toxicologist with knowledge of product formulations, regulatory requirements, and analytical evaluation of test results. Worked as a toxicologist for NSF International for 15 years in dietary supplements and functional foods. Have been self-driven and working from home for the…
Mechanical Engineering, Warning Labels, Human Factors
Expert is an Emeritus Professor at the University of Michigan and a registered professional engineer and consultant with over 35 years of experience as an expert witness. He specializes in warnings, labeling, and instruction manuals, consumer product design, process safety,…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
Protein aggregation, characterization, purification
Expert leads a team of exceptionally talented downstream scientists to develop scalable downstream processes for viral vectors for use in Gene, Cell and Oncolytic therapies and for Vaccine production and for therapeutics proteins and antibodies. Keywords: Process development, DSP, Downstream…