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Expert ID: 723903 North Carolina, USA

Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews

Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…

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: 733713 Texas, USA

Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

Expert ID: 734924 California, USA

Expert in Medical Device Engineering

He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…

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: 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: 732167 Maryland, USA

Expert in Healthcare Technology, Medical Devices, Clinical Engineering, Biomedical Engineering, and Hospital Technology

Expert is an Expert Consultant for hospitals, medical device companies, legal firms, and insurance carriers. Responsibilities consist of providing biomedical, clinical, and forensic engineering support to clients, that can include incident investigations, reports of findings, as well as expert witness…

Expert ID: 731095 California, USA

Expert in Medical Product Design and Development

I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers…

Expert ID: 730392 Pennsylvania, USA

Expert in Materials, Processes and Hermeticity Testing of Microelectronics for Aerospace and Medical Implants

He has demonstrated expertise in hermetic sealing and leak testing processes for cavity style packaged microcircuits intended for high reliability military, aerospace and Class III medical implants. He has worked as a hermeticity consultant for prominent military and aerospace companies…

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…

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