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Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Pharmaceutics
Expert is a process and chemical engineer with a Bachelor from Univercity Laval in Quebec City. He has more than 15 years experience in engineering, automation, validation of manufacturing equipments, clean utilities, pharmaceutical systems and computer systems (cGMP, GAMP5, CFR-21…
IT: Software Consulting, Manufacturing and Supply Chain (Warehouse and Inventory) Management and Traceability, and CGMP
Expert is an operationally focused, multi-disciplined, senior IT professional specializing in the installation and/or project recovery of complex/multi-dimensional manufacturing and supply chain-related systems and equipment. He is highly technically and operationally but with the abilities experiences, and temperament needed to…
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…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
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…
Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
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,…
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.…
Injury Biomechanics, Biomaterials, Artificial Joint Implants, Tribology
Expert has applied her mechanical engineering background to biomaterials, biomechanics and nanotechnology for implantable devices in many industries. She has selected surface engineering process coatings, developed new operating procedures to mechanically test biomaterials used for orthopedic and injury biomechanics applications,…