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Expert ID: 722341 New Jersey, USA

Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation

Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…

Expert ID: 721920 Virginia, USA

Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals

Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…

Expert ID: 107998 New Jersey, USA

Expert in Manufacturing, Project Management

Expert (pronounced ko-val-ski, ) has conducted seminars and instructed consultants on how to utilize state-of-the-art project management techniques. He can develop project plans and evaluate project management software and techniques. He can assist or critique how to set up, schedule,…

Expert ID: 719038 New York, USA

Expert in Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management

Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…

Expert ID: 108247 New York, USA

Expert in Fish Processing, Kosher Foods, Halal Foods,

COMPOSTING. Expert is currently working on static, natural air flow composting systems for various fish wastes and cafeteria food wastes. Small-scale systems, including potentially indoor systems, are also being explored. FISH MEAT. He is currently involved with new product development…

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…

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