Consultant Profiles - Design & Validation Services for Medical Device Manufacturers
David Albert, MS, DPM, PhD – Materials characterization, toxicology, biological safety Darin Kent, PhD, DABT – Biological safety, toxicology, microbiology, chemistry David Parente, MBA – GMP compliance, sterility, product safety, biocompatibility Mary Cao, BS - Sterility assurance, microbiology Kerri Johnson, BS - Biological safety, biocompatibility, material equivalency, toxicology |
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Dave Albert is an internationally recognized scientist and thought leader in the domain of chemical characterization of materials, and in the use of materials characterization to perform biocompatibility risk analysis. A prolific publisher, Dave has worked as a chemist in industry and academia for over 30 years. His honors include: 1990-1995 - Who's Who in Science and Engineering; 1995 - Who's Who in Medicine and Healthcare; 2008 Medical Device & Diagnostic Industry's 100 Notable People in the Medical Device Industry. He holds a Ph.D in Chemistry from Trinity College, a M.S. in Biochemistry and Endocrinology from Bowling Green State University, a D.P.M. form the Ohio College of Podiatric Medicine, and a B.S. in Pharmaceutical Sciences from the University of Toledo. |
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Darin Kent is an expert at applying chemistry and toxicology to assess biological risk, as well as interpreting chemical characterization data and biocompatibility testing data to establish biological safety. He has over 20 years experience in the chemical and toxicological sciences, including several years as a nonclinical study director for NAMSA where he designed and oversaw in vivo toxicology studies in compliance with GLP regulations. Previously, he served as senior scientist for Commonwealth Biotechnologies, Inc. in Richmond, Virginia. Darin prepares risk assessments and reports, assists clients with the preparation of submissions to the FDA and other notified bodies, and assists in the planning of testing and summarization of results ensuring compliance with the relevant regulatory requirements and standards. Darin is a Diplomate of the American Board of Toxicology (DABT). He earned a Ph.D. in organic chemistry, and M.S. in chemistry from the University of California, San Diego; and his B.S. in biochemistry from California State University, San Francisco |
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A medical technologist by training, Dave Parente is Operations Manager for the Alquest Design & Validation Services Group. He brings a broad and substantial regulatory perspective to clients, having worked as a chemical engineer and Quality Assurance & Regulatory Compliance specialist, and Laboratory Managet for Terumo Medical Corp. In those roles he performed or oversaw material testing, bioclinical qualifications, laboratory testing, GMP compliance, sterility assurance, product safety, material biocompatibility and GMP training. Dave also worked as Operations Manager for NAMSA, with oversight of laboratory testing operations and staff. He earned his MBA from Wilmington College, with undergraduate degrees from Rutgers University (New Brunswick, NJ) and Thomas Jefferson University.
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A material science chemist and researcher, Mary Cao is a Senior Consultant and advises clients in need of consultation regarding biological safety evaluation, product safety, and accelerated aging and package integrity studies. Her background includes six years with Kimberly-Clarke Corporation as a product research scientist; six years with NAMSA as a chemistry department supervisor; and 2 years as a pharmaceutical chemist with ARLI. Mary earned her Bachelor of Science in Chemistry from the University of Florida. |
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Kerri Johnson advises clients in need of consultation regarding safety evaluation, biocompatibility, and material equivalency. In addition to preparing risk assessments and reports, she conducts gap analyses, and assists in the planning of testing and summarization of results to ensure compliance with applicable regulatory requirements and standards. Kerri served as nonclinical GLP study director for NAMSA and also has participated in a variety of sponsor and FDA audits. She earned her Bachelor of Science in biology from Bowling Green State University.
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