Inspection Readiness: 10 Things To Avoid During Your Next Inspection
Inspection Readiness is an important element to any quality [...]
U.S. FDA Pre-Approval Inspections (PAI)
If you have worked in this industry for at least a few years you have probably heard the phrase “PAI” thrown about. What is a PAI? Why is it important? And how can I best position my company and our product?
Help My FDA Inspection is 48 Hours Away!
Last minute FDA preparations. Are you frantically trying to prepare for an FDA inspection or Quality Audit and have very little time? Here is a listing of items you should prepare and review. If you still need a little help - Give us a call.
Getting Ready For Quality Audits And FDA Inspections
What can I do to get ready for a quality audit or inspection by the U.S. FDA? Who do I need to prepare on my site? What do I do about known gaps in our systems? Read this article to learn more.