Ms. Koeneman’s expertise in clinical laboratory diagnostics, quality assurance, regulatory compliance, and laboratory developed tests will bring great value to our medical device clients.
ROCHELLE, Va. (PRWEB) August 26, 2020
NDA Partners Chairman Carl Peck, MD, announced today that Cynthia Koeneman, a clinical laboratory science professional, has joined NDA Partners as an Expert Consultant. Ms. Koeneman is an expert in clinical laboratory diagnostics, quality assurance, regulatory compliance including CAP and CLIA regulations, laboratory developed testing, and IQCP.
Most recently, Ms. Koeneman served as Microbiology Laboratory Manager for Sonora Quest Laboratories (Laboratory Sciences of Arizona) where she was responsible for microbiology policies and procedures, ensuring regulatory compliance, CAP readiness, and testing including bacteriology, mycobacteriology, molecular, and mycology for 6 Banner hospitals in Arizona. She also served as Microbiology Technical Supervisor, Technical Coordinator, and Medical Technologist with Sonora Quest Laboratories in prior roles. In her early career, Ms. Koeneman served as Medical Technologist at Northwest Medical Center in Tucson and Laboratory Technical Assistant in cytology at Kaiser Permanente.
“Ms. Koeneman’s expertise in clinical laboratory diagnostics, quality assurance, regulatory compliance, and laboratory developed tests will bring great value to our medical device clients. We are pleased to welcome her to NDA Partners,” said Dr. David Feigal, Manager of NDA Partners’ medical device practice.
Ms. Koeneman earned her MBA from the University of Arizona Eller College of Management and bachelor’s degree in biology from Portland State University in Oregon. She is certified by the American Society of Clinical Pathologists (ASCP) as a Medical Technology Scientist and Diplomate in Laboratory Management.
About NDA Partners
NDA Partners is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.
Earle Martin, Chief Executive Officer