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Change Management Change Management U.S. Food and Drug Administration (FDA) U.S. Food and Drug Administration (FDA) Failure Mode and Effects Analysis (FMEA) Failure Mode and Effects Analysis (FMEA) Validation Validation Six Sigma Six Sigma 5S 5S Standard Operating Procedure (SOP) Standard Operating Procedure (SOP) Regulatory Affairs Regulatory Affairs Corrective and Preventive Action (CAPA) Corrective and Preventive Action (CAPA) U.S. Title 21 CFR Part 11 Regulation U.S. Title 21 CFR Part 11 Regulation Change Control Change Control Cross-functional Team Leadership Cross-functional Team Leadership
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