Below are some nice links from regulatory websites explaining CAPA’s.
FDA CAPA Process:
https://www.fda.gov/iceci/inspections/inspectionguides/ucm170612.htm
FDA CAPA Regulations:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.100
ICH Q10 CAPA:
RSS - Posts
Leave a Reply