Tag Archive for Failure Investigation

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,…


Risk Assessment: When is One Necessary?

Q: Can you tell me when I need to perform a risk assessment?A:  I believe a risk assessment is always necessary. For everything you produce, you should have a product risk assessment that provides you with an understanding of how your product design may impact patients…