Course Description

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

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Learning Objectives

• Review how new regulatory requirements are being incorporated into inspections
• Discuss the CPGM and rules that support changes in inspection focus
• Assess the FDA’s application of the inspection manual contents as reflected in regulatory communication
• Examine steps for preparation of an inspection

Who Should Attend

• Professionals from Academia whose institutions or investigators hold INDs or IDEs, or whose institutions support clinical research with Site Management Organizations (SMOs)
• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Coordinators
• Sponsor-Investigators
• Sponsor and CRO Representatives

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.