Course Description

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of 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 some of the top 10 inspection findings from the Annual BIMO Inspection Metrics, and discuss appropriate corrective and preventive actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant.

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Learning Objectives

• Critically assess the number of major and critical Annual BIMO inspection findings
• Provide examples of the Annual BIMO top inspection findings
• Discuss how to prevent major and critical inspection findings
• Apply the right corrective actions to resolve the major and critical inspection findings

Who Should Attend

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

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.