Corrective and Preventive Action (CAPA) 820.100 & ISO 13485 § 8.4 & 8.5 (Executive Series #45)
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YouTubeQuality Systems Explained
Corrective and Preventive Action (CAPA) 820.100 & ISO 13485 § 8.4 & 8.5 (Executive Series #45)
Links 21 CFR 820.100: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.100 ISO 13485:2016 § 8.4, 8.5: https://www.iso.org/standard/59752.html Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download o Chapter 3 Tasks 8 o Chapter 6 Task 22, 23 Corrective and Preventive ...
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