This is one of the reasons why it's reviewed during all FDA routine inspections - both level 1 base line and level 2 abbreviated inspections. The purpose of corrective and preventive action, again, is to aid in adequately assessing the effectiveness of your overall quality system. So by the end I want to you walk away with these learning objectives and understand these concepts: Know the purpose of corrective and preventive action have the ability to distinguish between each of the defined terms understand the requirements in CFR 8120 - the quality systems regulation identify various types of data and tools that can be used to meet those regulatory requirements recognize examples and best practices and of course, be aware of compliance concerns. We all share the same common goal to ensure safe and effective medical devices on the market, and corrective and preventive action ensures that big or reoccurring problems are either resolved, or do not occur in the first place. During that time I have worked with both the Office of Regulatory Affairs and the Office of Compliance on educational outreach, and understand the agency's expectations for quality. I worked in the industry for close to 15 years, establishing quality systems, including developing effective corrective and preventive action systems. The big questions are you able to identify them and what do you do about them? Everyone knows the problems such as nonconformities can and do occur. It is a gauge to the health of the quality of your system. The topic of corrective and preventive action is an important one. My name is Joe Tartal and I'm the Postmarket and Consumer branch chief in the Division of Industry and Consumer Education.
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