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Expert ID: 730278 Alabama, USA

Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s

Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…

Expert ID: 723699 Colorado, USA

Expert in Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.

Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…

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: 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: 720664 New Jersey, USA

Expert in Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization

Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…

Expert ID: 733346 Connecticut, USA

Expert in 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,…

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: 730610 Canada

Expert in GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering

He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…

Expert ID: 728217 Maryland, USA

Expert in QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing

Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…

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