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Corrective and Preventive Action – Background & Examples

Corrective and Preventive Action Background & ExamplesPresented by:Kimberly Lewandowski-WalkerFood and Drug AdministrationDivision of Domestic Field InvestigationsOffice of Regulatory AffairsOverview Background on Corrective and Preventive Action (CAPA) Requirements Quality System (QS) CAPA (21 CFR ) Link Between CAPA and Other QS Regulation Requirements Examples on CAPA Guidance and Other ResourcesPurpose of the CAPA Subsystem Collect and Analyze Information based on appropriate Statistical Methodology as necessary to detect recurring quality problems Identify and Investigate Existing and Potential Product and Quality Problems Take Appropriate, Effective, and Comprehensive Corrective and/or Preventive ActionsCAPA Subsystem in ContextDesign Design ControlsControlsMaterialMaterialControls ControlsRecords,Records,Documents, &Doc

•Nonconforming Material Reports •Equipment Data •Scrap/Yield Data •Rework Data •Returned Product •Internal Audits •Process Control Data •Acceptance Activities EXTERNAL SOURCES INTERNAL SOURCES

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