Corrective and Preventive Action Basics
Corrective and Preventive Action BasicsNovember 4, 2014Joseph TartalPostmarket and Consumer Branch ChiefDivision of Industry and Consumer EducationOffice of Communication and EducationCenter for Devices and Radiological Food and Drug Administration2Learning Objectives Know the purpose of Corrective and Preventive Action Have the ability to distinguish between each defined term Understand the requirements in 21 CFR 820 Quality System Regulation Identify various types of data and tools Recognize examples and best practices Be aware of compliance concerns3Purpose of the Corrective and Preventive Action Subsystem To collect and analyze information to identify actual and
2 Learning Objectives • Know the purpose of Corrective and Preventive Action • Have the ability to distinguish between each defined term • Understand the requirements in 21 CFR 820 Quality
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