Course Description

A Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance.

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Learning Objectives

• Discuss an overview of sponsor and Clinical Investigator responsibilities
• Explain how to identify the active elements of a functional Quality System at the clinical research site
• Discuss how implementation of a Quality System can assist in the requirements for meeting obligations of sponsors and Clinical Investigators
• Determine how Quality System overlaps with FDA and ICH Guidance
• Examine recent compliance concerns and how applying the Quality System framework at the site level can address them

Who Should Attend

• Directors of Clinical Operations at clinical research sites
• Clinical Principal Investigators
• Clinical Research Coordinators
• Clinical Research Associates
• Project Managers
• All Clinical Research Personnel involved in selecting and/or overseeing clinical research sites

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.