Converting CAPA to an Advantage: For Further Reading

Medical Devices: Current Good Manufacturing Practice, 21 CFR 820
www.fda.gov/cdrh/fr1007ap.pdf

Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR 58
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

Medical Device Quality System Manual: A Small Entity Compliance Guide
www.fda.gov/cdrh/dsma/gmpman.html

Medical Device Reporting
www.fda.gov/cdrh/mdr

Medical Device Recalls, Corrections, and Removals
www.fda.gov/cdrh/devadvice/51.html

Guide to Inspections of Quality Systems
www.fda.gov/ora/inspect%5Fref/igs/qsit/qsitguide.htm

AdvaMed Points to Consider When Preparing for an FDA Inspection under the QSIT Corrective and Preventive Action Subsystem
www.advamed.org/NR/rdonlyres/E54C4BA9-A454-4FFE-8480-A7807529C9CC/0/pointstoconsider6501.pdf

Investigational Device Exemptions, 21 CFR 812
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812

Guidance for Industry: Product Recalls, Including Removals and Corrections
www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm

ISO 13485:2003: Medical Devices —Quality Management Systems—Requirements for Regulatory Purposes
www.iso.org