Melissa Eitzen, MT(ASCP), MS, RQAP-GLP
Director, Regulatory Operations
Institutional Office of Regulated Nonclinical Studies
Education and Certifications:
- Registered Quality Assurance Professional in Good Laboratory Practices [2007], Society of Quality Assurance
- Master of Science in Instructional Technology [2005],
University of Houston-Clear Lake, Houston, TX - Graduate Certificates in Performance Technology and Online
Distance Education [2005], University of Houston-Clear Lake, Houston, TX - Registered Medical Technologist [1984], American Society of Clinical Pathology
- Bachelor of Science in Medical Technology [1984], Indiana
University School of Medicine, Indianapolis, IN
Overview:
Ms. Melissa Eitzen provides strategic planning for regulatory activities by working closely 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, reviewing SOPs, providing compliance education, negotiating sponsor Quality Agreements, and assuring QAU oversight of regulated studies. Ms. Eitzen has thirty-five years of laboratory and quality assurance experience, including laboratory development and accreditation, management, quality control, equipment validation, regulatory compliance, and education development. Her experience in development of quality systems to meet regulatory requirements began in 1985 when she developed a quality system infrastructure for a new environmental testing laboratory that resulted in dual accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) and American Industrial Hygiene Association (AIHA). In 2004, Ms. Eitzen led the efforts to develop a GLP Program at UTMB by establishing an independent Quality Assurance Unit (QAU), document archive, campus-wide working groups, and education curriculum supporting the development of Quality Systems based on the principles of Good Laboratory Practices. Ms. Eitzen specializes in regulatory program development, leveraging the GLP (21 CFR Part 58) regulations as a quality system for data reproducibility, regulatory support of Medical Countermeasure (MCM) product development specializing in maximum containment (BSL-4) laboratories, FDA Animal Rule studies, scientific rigor and reproducibility, and regulatory education and mentoring.Ms. Eitzen is a former President of the Society of Quality Assurance (SQA), former Chair of the SQA University Specialty Section, and is a founding member and Co-Chair of SQA's International Mentoring Program. Ms. Eitzen is also an Honorary Life Member of the Research Quality Association, an invited member of the OECD Discussion Group on the implementation of OECD Principles of GLP, and currently serves as Co-Principal Investigator for a collaborative educational project with the U.S. Food and Drug Administration on "Achieving Data Quality and Integrity in Maximum Containment Laboratories."