Course Description

Informed consent irregularities remain one of the leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of FDA Warning Letters addressing informed consent inspection findings, and discuss appropriate corrective and preventive actions (CAPA). Learners will come away with solutions to avoid common informed consent pitfalls, and ultimately, avoid inspection findings. Participants are encouraged to share their experiences as we discuss methods to aid in compliance through appropriate techniques for the informed consent process. Tools will also be provided to assist in compliance.

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Learning Objectives

• Examine the major and critical inspection findings related to the informed consent procedure
• Discuss how to prevent major and critical inspection findings related to the informed consent procedure
• Implement the right corrective actions to resolve the major and critical inspection findings related to the informed consent procedure

Who Should Attend

• Principal Investigators
• Compliance Professionals
• Clinical Research Coordinators
• Clinical Research Associates
• Regulatory Affairs Professionals
• Auditors and Inspectors
• Trainers and Educators

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

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