Melissa Eitzen, MT(ASCP), MS, RQAP-GLP is the Director of Regulatory Operations for the Institutional Office of Regulated Nonclinical Studies. Ms. Eitzen partners with investigators to assure data reproducibility and regulatory compliance by implementing customized quality systems, performing compliance gap analyses, developing quality management plans and data management plans, providing compliance education, and negotiating Quality Agreements. Ms. Eitzen’s expertise includes regulatory program development, leveraging the GLP regulations as a quality system for data reproducibility, regulatory support of Medical Countermeasure (MCM) product development specializing in high and maximum containment (BSL-3 / BSL-4) laboratories, course development, and mentoring.
Ms. Eitzen has over thirty-five years of laboratory and program development experience. She is a frequent lecturer within UTMB’s Graduate School of Biomedical Sciences, serves as a faculty member for the Texas Gulf Coast Consortia Rigor and Reproducibility and Data Integrity workshops, and is a frequent invited speaker at national and international conferences. Ms. Eitzen is a former President of the Society of Quality Assurance (SQA), former Chair of the SQA University Specialty Section, founding member of the SQA international Mentoring Program and was awarded as an Honorary Life Member of the Research Quality Association (United Kingdom). Ms. Eitzen currently serves as an invited member of the OECD Discussion Group on the implementation of OECD Principles of GLP and the World Health Organization Expert Group on COVID-19 Animal Models, and serves as co-Principal Investigator for a collaborative educational project with the U.S. Food and Drug Administration entitled Academic Development of a Training Program for GLP in ABSL 3/4. She has also served as a peer reviewer for journal articles, funding proposals, and (2019) the National Academies of Sciences, Engineering, and Medicine Draft Report: Assuring Data Quality at U.S. Geological Survey Laboratories.
Ms. Eitzen holds a Master of Science degree in Instructional Technology from the University of Houston Clear Lake where she also earned graduate certificates in Performance Technology and Online Distance Education. She also holds a Bachelor of Science degree in Medical Technology from the Indiana University School of Medicine and is a Registered Quality Assurance Professional in the GLP regulations (RQAP-GLP).
For this project, Ms. Eitzen will provide education (e.g., good documentation practices following the ALCOA principles, quality management systems, etc.) to test site personnel and serve as an advisor to the Co-Principal Investigators with regards to data quality and integrity, including investigations initiated as a result of systematic errors.
Email: mmeitzen@utmb.edu