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Expert ID: 732176 California, USA

Expert in Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices

Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…

Expert ID: 731085 India

Expert in TVET Training on good manufacturing practices.

ExpertSomanath has developed and implemented various good manufacturing practice training required for trainees undergoing vocational training in a Vocational Training Center. His areas of Training involves mainly in the attitudinal development in the area of Safety, Quality,Cost Reduction and Continual…

Expert ID: 725805 France

Expert in Regulatory Affairs for Cosmetics, Fragrance, Health Products, Good Manufacturing Practices

Expert has been nominated in 2009 as a National Court Expert in Paris (Chemicals – Cosmetics – Perfumes and Cosmetic Good Manufacturing Practices) He became licensed as well in 2009 on toxicological and safety evaluation for cosmetic products (Faculty of…

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: 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: 733372 New York, USA

Expert in 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…

Expert ID: 732037 North Carolina, USA

Expert in Flavors and Fragrances Manufacturing, Compounding and Sample Services

Expert has improved flavors manufacturing, flavors compounding and sample lab best practices across multiple international sites for a top multinational Fragrance and Flavors company. Expert applies this experience to evaluate facilities, develop and justify proposals to optimize and deploy practical…

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…

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