FDA Warning Letters

FINAL Part 3: Invisible Ink in GLP and GCP Research

“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”

Part 2: Invisible Ink in GLP and GCP Research

“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?

The Easy Way to Research Your Inspector

When the FDA notifies you of an upcoming inspection, sometimes you only have minutes to prepare. You need information, and you need it fast. Most companies start with a Google search or call their colleagues to get information about their inspector. But with FDAzilla, you have more than anecdotes. You have real statistics. In this post, we will walk through an FDAzilla inspector profile — a snapshot of the inspection and citation history of one of the 4,000+ FDA inspectors in our database.