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Quality by Design, Good Laboratory Practices, Intellectual Property Security, ICH and FDA Compliance
As the former CIO of a Fortune 50 product development and commercialization subsidiary, and the executive tasked with building an ISO compliant records management program, Expert has had more than 15 years of experience planning, developing, implementing and then managing…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
Failure Analysis and Remaining Life Assessment For Metallic Structure; Welding Technology & Metallurgy
Expert is a Researcher and consultant specializing in mechanical failures and welding. He performs analyses of failed consumer and industrial products/equipment, as well as metallurgical laboratory analyses. He also conducts engineering evaluations and provides analyses and opinions on the fracture…
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…
IVD Assays and Diagnostic Tests Development
Expert's areas of expertise include the following: IVD (in vitro diagnostics) clinical laboratory regulation molecular diagnostics blood assay diagnostic instrumentation assay development CLIA-88 (Clinical Laboratory Improvement Amendments of 1988) clinical laboratory regulation quantitative risk analysis (risk assessment) laboratory management GLP…
Medical Device Pathology
His areas of expertise include the following: • Inflammation and vascular cell biology/pathology • Medical device, drug delivery, and biomaterials histopathology • All phases of preclinical research • Regulatory, R&D, sales and marketing, and clinical issues He was a founding…
Materials Technology, Powder Metallurgy, Advanced Ceramics, Process & Product Development, R&D, Lean
25+ years of experience in successfully managing and spearheading R&D and Operations projects to completion. Developed new products and processes, led cross-functional teams, project management and implementation, mentored subordinates and peers, provided team building and leadership, problem solving skills, and…
Forensic Drug Chemistry –Controlled Substances, Forensic Toxicology–Blood Alcohol, Drugs DWI
Expert has 37 years experience in the field of Forensic Drug Chemistry in the testing of evidence submitted to determine the presence or absence of a controlled substance and expert testimony. He is also qualified in Forensic Toxicology in both…
CLIA/CAP/NYS Laboratory Testing; Tissue/Cornea/Live Cell Donor Suitability
Expert is one of the world's leading experts on eye and tissue banking, as well as being a pioneer in the field of personalized medicine. His company provides CLIA-qualified laboratory directors to labs throughout the United States, as well as…
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…