For over a decade, QIS has designed proactive strategies to assist companies in reaching successful regulatory milestones in their drug and device approval process. Founder and President, Donna G. Hartzfeld, Ph.D. has over 18 years of Quality and Laboratory compliance experience in API, pharmaceutical, medical device, biotech, combination products, biologics and dietary supplements industries.
Dr. Hartzfeld holds a doctorate degree in PhotoOrganic Chemistry from Arizona State University. She was awarded an academic doctoral fellowship from the Patricia Roberts Harris Foundation during 1992-1995. Her thesis research was multi-disciplinary incorporating elements of biochemistry, organic synthesis, analytical analysis and physical chemistry to study photoinduced pyrimidine dimer radical anion splitting in DNA Photolyase model systems to elucidate the enzymatic mechanism of electron transfer in UV-damaged DNA repair processes. Techniques utilized were organic synthesis, NMR, MS, X-ray, UV/VIS, HPLC, steady-state and time-resolved laser fluorescence spectrophotometry and resulted in several publications.
During her Doctoral studies, she served as a USA representative at the NATO-Advanced Study Institute School of Photobiology in Medicine at Sardinia, Italy, participated as an invited Researcher at California Institute of Technology in Pasadena, California, inducted into the Academic Honorary Chemical Society of Phi Lamba Upsilon (PLU), and was recipient of the National Scholar of the Year Award from the National Professional Chemical Fraternity, Alpha Chi Sigma (AXE) in 1994 as a result of her cutting edge research activities.
Entering industry, Dr. Hartzfeld was challenged with launching a small pharmaceutical cGMP manufacturing facility, incorporating a comprehensive quality management infra-structure and building a fully functional analytical Quality Control laboratory. The facility successfully passed its first Pre-Approval Inspection (PAI) in just under 4 years from conception with no FDA observations.
She has academic teaching experience at the university level in organic chemistry, general chemistry and biology and anatomy laboratories. She enjoys applying her academic teaching skills to industrial training and to the development of innovative, educational materials to accompany inter-active training sessions.She currently serves on the Advisory Board as the regulatory compliance advisor of a project and document software management company to the Life Sciences in Phoenix, Arizona. She is and has been a member of various professional associations such as RAPS, DIA, ASQ, SQA.