The trick with any FDA inspection preparedness program is to reduce the risk of surprise by understanding FDA history and tendencies. But like most professionals in this industry, you’re probably [...]
How to Prepare for a GMP Inspection for Small and Virtual Companies by Barbara Unger, GMP Quality Expert and GMP Regulatory Intelligence Editor-in-Chief Preparing for GMP inspections, particularly pre-approval inspections, can be a challenge when [...]
Today I’d like to show you how to do [...]
This Special Report represents the 3rd year that we [...]
It’s easier than you think! Let’s... Start with a [...]
Want to learn how to do a keyword search in FDA warning letters? Watch the video or read the post below. We have about 15,000 warning letters in our database. You can search on any term or combination of terms in any of these documents. As an example, I’m going to search for “media fills”...
We continuously monitor, collect, sort, tag, and link data from multiple agencies to enable bespoke reports, user-friendly searches, and automated alerts. Equipped with this unrivaled information, you’ll reduce regulatory risk, maximize actionable insights, and minimize research time.
I recently discovered a gap in my education. Like you, [...]