Tag Archive for CAPA

Checklist for Complaint Handling Procedures

Proper management and follow-up of product complaints is one of the major stumbling blocks for FDA-regulated companies. Compare your existing Complaint Handling Procedures against this checklist of best practices: √ Define your complaint sources √ Decide how a complaint is…


Internal Quality Audits: What to Target

Q: With your experience as an FDA investigator and independent auditor, can you advise me on some specific things to look for when I’m conducting internal quality audits? A: First, make sure all your required Quality System procedures are defined,…