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Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…

Expert ID: 726234 Minnesota, USA

Expert in machine tools, heavy equipment, and aerospace manufacturing technologies.

Expert began using CAM in its earliest stages, using Compact II and DataCut to created machine instructions to Numerically Controlled (NC) Machine Tools. He advanced to writing scripts and macros in Automatically Programmed Tools (APT) to perform machining functions around…

Expert ID: 734908 Georgia, USA

Expert in 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…

Expert ID: 732491 Washington, USA

Expert in 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…

Expert ID: 731331 Illinois, USA

Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence

Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…

Expert ID: 730090 United Kingdom

Expert in Manufacturing, Automation, Engineering Design, Operations, Control Engineering, Food Factories

Long-standing designer of complex factory automation systems. Expert witness work has involved determining causes of program failures that have led to serious factory fires and equipment failure, as well as failure to perform to specification. Three major fire studies (milk…

Expert ID: 729722 Canada

Expert in Manufacturing, Process Development, Machining, Cutting Tools, Innovation, Training

Expert has extensive knowledge and experience in the applications of metal cutting and cutting tools and in research in manufacturing technologies. He has worked and taught for more than 38 years on R&D projects including topics such as: manufacturing process…

Expert ID: 729349 Michigan, USA

Expert in Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization

Technological / Scientific Infrastructures Speed to Markets • Advising and Strategically Coordinating with the Following Agencies:  World Health Organization COVID-19 Accelerator Cure Project  Linking Collaboration Platforms for Best in Class Teams around the world  The Directorate for…

Expert ID: 729236 California, USA

Expert in Medical Device Technology, Design and Manufacturing

Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…

Expert ID: 728603 Massachusetts, USA

Expert in Chemistry R&D and cGMP Manufacturing, Pharmaceutical Development

Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…

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