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Discrete Event Simulation, Debugging Simulation Models, and ExtendSim
He is an expert in developing software and solutions for end-users of complex discrete event simulation software, ensuring client needs are attained while simultaneously evangelizing the attributes of corporate products. Expert has a well-rounded background in discrete event simulation and…
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…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Technology – Strategy, Product Mgt, Agile Development, Marketing, Go to Market and Channel
Expert is a Technology Entrepreneur with over 20 years of experience in Executive and Leadership roles spanning Strategy, Product Management, Technology Alliances, Product Lifecycle, and GTM Sales Enablement at companies including Dell, Honeywell, IBM, Tata Consulting Services, and CAD/CAM Technologies.…
Bulk Metal Forming, Forging, Modelling & Simulation, Process Improvement
Successful project facilitator with knowledge in the optimisation of key manufacturing process parameters used in the bulk metal forming and forging industries. An innovative and creative individual with strengths in problem solving, critical thinking and project management. Self-motivating with a…
Intellectual Property, Patents, Validity Invalidity, Infringement Noninfringement, Product Liabilty
Expert has extensive experience in product liability which include: Direct participation in more than 300 litigation cases with in-depth evaluations of multiple high-dollar claims and lawsuits. Forensic Analyses. Expert witness reports, inspections, accident reconstruction, photographs, occupant kinematics & injury causation,…
Formulation Development
Expert has over 20 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms and parenterals dosage forms with leading companies as TTK, Parke-Davis, Strides, Banner Pharma…
Medical Device Strategy, Up-stream Marketing and Commercialization
Expert has over 30 years marketing experience in the healthcare industry. During his career he has launched over 20 products in the USA and internationally. Products launched include electronic medical equipment, durable medical equipment, medical plastic consumables, and medical software.…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Leadership, Management, Product/Mfg. Engineering, Energy, Fuel Cells, Fuels/Infrastructure
Expert was previously the Director responsible for the global deployment of advanced technology vehicle fleet projects at General Motors. He led the deployment of the Chevrolet Electric Fuel Cell Vehicle (FCEV) Fleet. He led the FCEV “Project Driveway” and the…