Q: What are FDA’s expectations for internal audits? For example, how frequently should we conduct internal audits? And what documents does FDA expect to see to prove we’re actually doing the audits? A: First of all, FDA expects you to…
Complaint Investigation: Recommended FDA Time-Frames
Q: I have a question about complaint investigation. What does FDA consider “timely” in terms of closing investigations of complaints? A: A minimum of 30 days after becoming aware of the complaint — that’s how long you have to determine if…
How to Document Validation Testing to FDA’s Satisfaction
Q: Regarding the documentation of validation testing, if “pass” is not sufficient as objective testing evidence, would FDA prefer video of the testing, or would screen shots of a large portion of the test cases be sufficient? A: FDA doesn’t…
Download an EduQuest Advisory on Your Kindle
An EduQuest Advisory for two FDA compliance challenges are now available for immediate download on KindleTM readers (and Kindle apps on Ipads and other mobile devices). An EduQuest Advisory is a brief but comprehensive white paper that provides practical FDA compliance advice from…
CAPA Definitions as Used by FDA and ISO
CAPA definitions and terms can sometimes be confusing. Nearly everyone stumbles over the proper use and application of the CAPA terms of corrections, corrective actions, and preventive actions. The following CAPA definitions clarify the differences and are consistent with interpretations…