Archive: Informed Consent Procedure: Lessons Learned from Inspection Findings

May 15, 2018 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

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.

Click here for complete trainer biographies

 

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