Glenda Guest, CCRA, TIACR, RQAP-GCP, FACRP, ACRP-MDP

Biography

Glenda Guest, CCRA, TIACR, RQAP-GCP, FACRP, ACRP-MDP is a credentialed monitoring (CCRA) training (TIACR) and auditing (RQAP-GCP) professional with 25+ years experience in a CRO environment with drug, device and nutritional product development, Ms. Guest currently provides routine and specialty GCP auditing services, mock FDA Inspections, regulatory product development and clinical quality system consulting and customized training on regulated research and Good Clinical Practice for her company Assured of Quality Consulting & Training and for NCRA, where she remains as Vice President of the Board.

Ms. Guest has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor, mock FDA investigator, regulatory consultant and senior trainer. Thus 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. 



An invited speaker at local and global professional meetings, she has been honored with ACRP and MAGI Top Speaker recognition and has been a recognized as a “Distinguished Speaker” for SQA for over 5 consecutive years.