In order to have the best chance for completing a successful GLP-compliant study, a number of fundamental elements are required. These elements begin with the due diligent vetting of select contract research organizations (CROs) to assure required technical capabilities and GLP compliance and end with a high-quality final report. This webinar will provide participants with insights into documentation and procedures that can be used to help ensure a GLP-compliant study from study design to final report.
Who Should Attend:
Anyone actively conducting or planning to sponsor GLP-compliant studies and those involved in the conduct of GLP-compliant studies.
About the instructor:
Ms. Fisher has more than 35 years of experience in toxicology testing and GLP study monitoring and compliance (with 16 of those years in a contract research organization). In her current position at Trinity Consultants, SafeBridge® Regulatory & Life Sciences Group, Ms. Fisher manages Quality Assurance (QA) and scientific consulting services, monitors toxicology studies from protocol development through final reporting, and offers QA services to Sponsors and testing facilities, which include data and report auditing, facility inspections/audits, and training for US and OECD GLP compliance. In addition, she assists with the preparation and quality reviews of US and international chemical/product registration submissions and pharmaceutical product risk assessments. Ms. Fisher earned her BS from Allegheny College and is a Registered Quality Assurance Professional (RQAP-GLP).
May 05, 2021 -- Online
11:00 AM Eastern time