Course Description

Faced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors. Steps for preparation, on-site auditing and follow-up actions will be explained. Interactive exercises will be incorporated utilizing FDA Warning Letters. Participants will learn how to perform root cause analysis (RCA) and prepare corrective and preventive actions (CAPAs).

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Learning Objectives

• Describe the anatomy of a regulatory inspection
• Recognize how to best prepare and manage expectations
• Discuss appropriate strategies for responding to inspection findings and implementing realistic and appropriate corrective and preventive actions (CAPA)
• Employ the right corrective actions to resolve the major and critical inspection findings

Who Should Attend

• Investigators
• Clinical Research Coordinators
• Clinical Research Associates
• Compliance Professionals
• Project Managers and Site Managers
• Quality Assurance Personnel

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A.

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