Glenda Guest BS, CCRA, RQAP-GCP, TIACR, FACRP, has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession with Norwich Clinical Research Associates (NCRA) within 1997. With 20+ years of regulated research experience and her extensive background in a clinical CRO environment, she has developed a unique perspective, not only of the regulatory requirements for pharmaceutical and device development and market approval but also the insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements. Ms. Guest is a published writer, certified clinical research associate, registered quality assurance professional (GCP) and a certified clinical research trainer. An invited speaker at local and global professional meetings and has been honored with the ACRP 2015 Global Conference Top Speaker Award, the MAGI Outstanding Speaker Award 2018 and SQA Distinguished Speaker 2017 and 2018.