Corrective and Preventive Action – Background & Examples
Overview • Background on Corrective and Preventive Action (CAPA) Requirements • Quality System (QS) CAPA (21 CFR 820.100) • Link Between CAPA and Other QS Regulation
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fmdic.org•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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