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Related Expert Areas


clinical laboratory regulation




Good Clinical Practice


Clinical Laboratory Improvement Amendments of 1988


clinical instrumentation


clinical laboratory equipment


clinical laboratory


clinical research


clinical enzymology


clinical microbiology


clinical immunology


clinical trial


clinical medicine


clinical chemistry


Clinical Laboratory Regulation Experts

The following experts are available as clinical laboratory regulation consultants and clinical laboratory regulation expert witnesses.  ORC experts are peer-recommended authorities who have been carefully selected and rigorously screened.
    Definition:  Clinical Laboratory Regulation - A regulation that applies to a clinical laboratory. For example, the Clinical Laboratory Improvement Amendments of 1988 apply to all laboratory testing used for the assessment of human health, or the diagnosis, prevention, or treatment of disease.

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Clinical Laboratory Regulation Experts
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Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and ... See full profile

Illinois (IL), USA

Expert in Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet ... See full profile

Massachusetts (MA), USA

Expert in Clinical Laboratory Testing, Interpretation, Quality Assurance and Reporting.
Expert was trained in clinical chemistry and toxicology and is a Fellow of the American Board of Clinical Chemistry, Academy of Clinical Biochemistry and has over 19 years experience directing clinical laboratories including forensic (drug testing) ... See full profile

Colorado (CO), USA

Expert in Biochemistry, Drug Development, Antibiotics, Proteins, Medicines, Pathogens, and Pharmaceuticals
Expert serves on the faculty of a University, Department of Chemistry and Chemical Biology. He previously held a senior scientist and lecturer position at ETH Zurich, Switzerland. His interests are at the interface of chemistry and biology, where he is a ... See full profile

Massachusetts (MA), USA

Expert in CLIA/CAP/NYS Laboratory Testing; Tissue/Cornea/Live Cell Donor Suitability
Expert is one of the world's leading experts on eye and tissue banking, as well as being a pioneer in the field of personalized medicine. His company provides CLIA-qualified laboratory directors to labs throughout the United States, as well as ... See full profile

Colorado (CO), USA

Expert in Immunology, Biotechnology
Dr Gutierrez has worked on research projects concerning the mechanisms of regulation of the immune ... See full profile


Expert in Microbiology Biotechnology, In Vitro Diagnostics, Public Health, Tuberculosis, Mycology, Archaea
Expert is adjunct Assistant Professor of Molecular Genetics and Microbiology for theExpert's Consulting Firm Health Sciences Center and a consultant to several medical and biotechnology companies. Prior to this Expert was the manager of a public health ... See full profile

New Mexico (NM), USA

Expert in Laboratory Medicine, Pathology, CPT Coding
Expert received his Doctor of Medicine degree from the University of Nebraska Medical Center, College of Medicine in 1986. He completed his residency in pathology and microbiology at the University of Nebraska Medical Center where he also obtained ... See full profile

Kansas (KS), USA

Expert in Allergy Immunology and Clinical Lab Immunology
Expert has a varied professional life. He has a busy private practice focused on hypersensitivity and immune disorders and asthma. He has unusual experience and recognition in dealing with food allergy of all types, including peanut anaphylaxis. See full profile

Texas (TX), USA

Expert in Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also ... See full profile

California (CA), USA

Expert in Healthcare Industry, Telemedicine, Healthcare Market Research, Best Clinical Practices, Urgent Care.
Expert has over 15 years of experience in clinical medicine. He has served as Medical Director and/or Department Chairman for 7 Emergency Departments nationally, focused on implementation of Clinical Best Practices. He has served as National ... See full profile

Texas (TX), USA

Expert in Genomics, Proteomics, Structural and Molecular Virology, Protein Biochemistry.
Expert has been working in the area of biochemistry for over 15 years. He can provide technical advice on genomics and proteomics projects. He has designed and developed custom projects. He performs data analyses. He can also conduct research on ... See full profile

Minnesota (MN), USA

Expert in 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 ... See full profile

Virginia (VA), USA

Expert in FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. See full profile

New Jersey (NJ), USA

Expert in Clinical Laboratory Medicine and Pathology: Toxicology, Immunology, Molecular Biology Testing, etc.
Experienced expert witness in personal injury, malpractice and wrongful death cases, Autopsy pathology, slide and record review. Expert is and an Independent Medical Examiner. Internal Medicine, Forensic Pathology and Toxicology. See full profile

California (CA), USA

Expert in Ophthalmology, Optometry, Plastic and Reconstructive Surgery, Pediatric Ophthalmology
The expert has over 25 years experience. Over 355 medical-legal investigations; 56 depositions and 13 court appearances. He has held the following educational titles: Professor, Chair of Ophthalmology; Professor, Physiology and Biophysics, Wright State ... See full profile

Ohio (OH), USA

Expert in Obstetrics and Gynecology
After becoming and ordained minister and conducting a 9 year extensive medical education at institutions on each coast (including California and Washington D.C.) expert served in a vast range of medical duties. He holds licenses to practice in Maryland, ... See full profile

Virginia (VA), USA

Expert in Clinical Microbiology, Infectious Diseases, and Healthcare Associated Infections
Expert has over 25 years experience in academic, hospital-based, and commercial diagnostic microbiology. He has held laboratory director positions in university and private hospital settings, and as the national director of microbiology in industry. See full profile

Texas (TX), USA

Expert in Epidemiology, Pediatrics, Infectious Diseases, HIV/AIDS, Immunology, Public Health
In her various positions at the Centers for Disease Control and Prevention, Expert has dealt with the ethical issues surrounding policy decisions involved in hemophilia-AIDS, transfusion-associated AIDS, AIDS in developing countries, AIDS ... See full profile

Oregon (OR), USA

Expert in Oxygen Therapy & Conservation, Biofeedback, Clinical Management Design, Electronics, & Prototyping
Expert has extensive clinical experience in asthma management and served on the ATS Standards Committee for COPD (Chronic Obstructive Pulmonary Disease) published in 1995. He developed an asthma clinical guidance system, developed three ... See full profile

California (CA), USA

Expert in Biotechnology
Expert has practiced biotechnology since 1973. He has worked primarily in the development and troubleshooting of manufacturing processes and immunoassays. He has developed reagents for 21 analytes ranging from large proteins and ... See full profile

Pennsylvania (PA), USA


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