Bronwyn Ramey-Hartung, PhD, HCLD (ABB)
The founder of Phoenix Laboratory Consulting, Bronwyn Ramey-Hartung, PhD, HCLD (ABB) has worked in research and commercial genetics laboratories for 20 years.
She was deeply involved in the growth and operation of one of the first laboratories CLIA-certified specifically to perform pharmacogenetic tests, at various times responsible for its assay development and validation, technology implementation, quality systems development and regulatory compliance.
She has edited two books on the evolution of bacterial cell shape and numerous articles and book chapters on subjects as diverse as reagent manufacturing protocols and bacterial biofilm culture. She is an invited peer reviewer for the journal Pharmacogenomics and the main author of a successful IDE application for Class II software protocols.
Dr. Ramey-Hartung is expert in the design and validation of Laboratory-Developed Tests; operations and certification of high-complexity clinical laboratory operations; the establishment of quality systems; regulatory compliance; and medical device validation and software. She holds a Certificate of Qualification for pharmacogenetics in New York state and is HCLD-certified by the American Association of Bioanalysts.
She lives with her husband and rambunctious sons in the rolling bluegrass east of Louisville, Kentucky.