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Expert ID: 722161 Connecticut, USA

Expert in Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.

As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…

Expert ID: 721133 North Carolina, USA

Expert in Medical Polymer Sterilization

MEDICAL POLYMER SELECTION; MEDICAL POLYMER STERILIZATION. With knowledge of material selection for medical devices, Expert has specific expertise in selecting materials based on cost, physical properties, radiation or other forms of sterilization, blood and tissue compatibility, permeability, and aging properties.…

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: 717866 Virginia, USA

Expert in Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology

Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…

Expert ID: 107897 South Dakota, USA

Expert in Medical Device Total Quality

FDA REGULATION. A significant portion of Expert's career has been devoted to FDA approval and regulation of medical devices, particularily those with significant risk. He is the President of a consulting company specializing in process validation, FDA/regulatory consulting, and auditing.…

Expert ID: 713381 Minnesota, USA

Expert in Medical Technology

A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…

Expert ID: 736551 Colorado, USA

Expert in Materials Engineering, Polymers, Metallurgy, Chemistry, Corrosion, and Adhesion Science

Expertise in chemistry, materials science, metals, polymers, corrosion, coatings and packaging. Expert has over 20 years of experience working as a technical consultant in materials engineering, polymers, metallurgy, chemistry, corrosion and adhesion science. She has been an advisor to companies…

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: 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…

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