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Infectious Diseases, Infection Control, Epidemiology, Public Health, and Pediatrics
Expert R. Expert was an author on the Centers for Disease Control and Prevention (CDC) Guideline for Prevention of Transmission of M. tuberculosis in Healthcare Settings and the WHO Guideline for Prevention of M. tuberculosis Transmission in Healthcare Settings 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…
Molecular Diagnostics, Molecular Biology, Public Health
Expert has extensive expertise in molecular diagnostics, particularly for infectious pathogens. He is an expert in test development using state of the art technologies, including real time PCR. He has developed and implemented many tests for the detection of pathogenic…
Immunoreagents, Clinical Reagents, Surfactant Science
Expert developed, created and adapted immunoassays for flagship auto analyzers. Using a variety of surfactants, he engineered reagents, controls and calibrators for immunoassays of thyroids (T3, FT3, T4 and FT4), reproductive hormones (FSH, LH, hCG and prolactin), anemia (B12 and…
Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert L. Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease). He developed an asthma clinical guidance system, developed three biofeedback systems particularly for asthma. He also developed…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
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…
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.…
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…