Course Description

Under federal regulation, sponsors are responsible for ensuring the integrity of safety and efficacy data submitted to the FDA to support their application; they are also responsible for ensuring clinical studies are conducted in accordance with the approved protocol. Audits are an opportunity to assess compliance and not just the quality of data, but the systems that generate that data. This web seminar will highlight the collaborative requirements for facilitating remote auditing and identify key considerations for future studies.

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Learning Objectives

• Review the purpose and process of audits
• Examine critical Clinical Investigator quality systems, subsystems, and processes
• Explore study risk assessments to inform the remote auditing plan
• Discuss the use of technology to verify objective evidence
• Address challenges and potential solutions of virtual audits
• Incorporate new FDA guidance and ISO standards to develop a remote audit process

Who Should Attend

• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Coordinators
• Clinical Principal Investigators
• IRB Administrators and Members

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.