Nan Huddy, MS, MBA, RQAP-GLP

Quality Specialist and Consultant in the areas of FDA/OECD Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), Health and Human Services (HHS) Human Subject Research, and human biospecimen/biobanking practices. Extensive experience and passion for mentoring laboratories or departments in developing robust quality or biospecimen-related processes. Up-to-date knowledge of quality for toxicology studies, clinical studies, and drug manufacturing. Detail-oriented problem-solver and decision-maker with excellent work ethic and high integrity. 

•    Compliance Trainer / Consultant / Mentor

•    Specialize in bridging the leap from research to regulatory compliance

•    FDA and OECD regulations and requirements

•    Vendor qualification audits

•    Patient privacy, and the ethical use of human biospecimens in research

•    Equipment/System/Software Validation and Change Management

•    Development and implementation of quality systems for inspection readiness

•    Hands-on approach including SOP writing, biospecimen tracking systems,
      clinical and GLP data reviews and auditing