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Expert ID: 107894 Ohio, USA

Expert in Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation

Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…

Expert ID: 107758 North Carolina, USA

Expert in Sterilization, Sterilizers

STERILIZATION; STERILIZER; AUTOCLAVE. Expert has over twenty years of experience in the design, production, and marketing of steam and gas sterilization equipment. His experience has covered small table top sterilizers through large bulk processing units. He has been responsible for…

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: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 718487 Illinois, USA

Expert in Sterile Processing Technology

ExpertKai Expert's formal training and industrial experience have provided him a solid foundation to design optimal heat sterilization processes for foods, pharmaceuticals, devices, biologics, and equipment. His activities in this field include low-acid canned foods, in-container or terminal heat sterilization…

Expert ID: 734912 Canada

Expert in 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…

Expert ID: 733645 North Carolina, USA

Expert in Pressure-Sensitive Tapes: Markets, Materials, Products, Processes, and Equipment

Expert has over 25 years' experience in the pressure-sensitive tape business. His experience includes operations management, and he has held COO and Senior VP titles alike. His total manufacturing experience spans over 40 years. Expert has devoted his career, respectively,…

Expert ID: 732014 New York, USA

Expert in New Product/Process Scale-up and Commercialization over many technology platforms;Team building; Background as expert witness

Expert holds a Ph.D. in Chemical Engineering. His expertise is in real-world, industrial product/process commercialization and optimization. He has devoted his career to taking initial, developmental quantities of new materials and organizing the necessary process steps to create commercial quantities…

Expert ID: 731924 Illinois, USA

Expert in 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…

Expert ID: 727427 Canada

Expert in Electron Beam Equiment for Sterilizing Medical Devices, and Irradiating Foods, Polymers and Wastes

Expert is one of two partners in a consulting firm. He is the former General Manager of AECL Accelerators. He planned and led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology. He set…

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