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Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Polymers, Plastics, Composites, Plastic Pipe, Composite Pipe, and Failure Analysis
Throughout his 41-plus-year career experience in the plastics industry, Expert has worked in research and development, product development, technical services, application development, failure analysis, sales, marketing, market development, business development, R&D management, small business unit management, trade association management and…
Polymer Characterization, Analytical Chemistry, Design of Experiments for Complex Problem Solving
Expert performed polymer characterization using a wide variety of analytical techniques: Size Exclusion Chromatography (SEC/ GPC), Field Flow Fractionation, HPLC, Dilute Solution Viscometry, Rheology, Thermal-Mechanical Analysis (DSC, TMA, DMA), Light Scattering, Optics (Birefringence, Dichroism, Turbidity). He developed structure-property-performance relationships in…
Mixed Analog and Digital Microelectronics, Electrical Circuits and Systems, Forensic Engineering
Expert is a Licensed Professional Electrical, Electronics Engineer, and Expert Witness practicing forensic and technical electrical engineering consulting. His forensic engineering practice includes forensic investigation, advising, reporting and testimony in electrical, electronic, communication, and electro-mechanical control-system matters regarding intellectual property,…
Environmental Services, Regulatory Compliance, Waste Transportation & Disposal, Landfills
20+ Years Environmental Management Experience / Leader in Business Strategy & Acquisition / Western US Facilities Oversight / Training & Regulatory Compliance / Human Resource Management & Professional Growth Expert is a results-driven business professional with 20+ years’ experience in…
Bridge Design, LS-DYNA, Concrete Pavements, Road Smoothness, Structural Analysis, Failure Analysis
Professional Structural Engineer with over 20 years of academic and consulting experience in the structural analysis, design, long-term monitoring, and condition assessment of highway bridges and pavement structures. Experience is also extended to the design and construction of water-front structures,…
Soil Properties,Stormwater and Flooding, Waste Management, Landfilling, Groundwater, Coal Ash, fly Ash landfills, Hazardous Waste
Expert has a Ph.D. and over 90 publications in specialized areas. He has carried out expert consulting, research, and provided expert advisory services. He was hired by a legal firm to provide expert assessment of flooding that resulted due to…
Systems and Processes in Clinical & Regulatory in Pharmaceutical, Healthcare and Health Insurance
Accounting ethics | Expert is a CPA, member of AICPA and NYSSCPA. Expert has global experience with pharmaceuticals, focused on corporate integrity agreements and Physician Payment Sunshine Act, interacting with finance, audit, clinical and regulatory teams, physicians and non-physician investigators,…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…