We are ready for the FDA

[gsabc]

My QA Manager and I went to our other facility and played at being auditors. We went through all the typical parts of the quality system that outside auditors (FDA or otherwise) look at. In some ways, it was nice to see that my site isn't the only one behind in completing documentation. Sometimes it builds up and there are higher priority items that need to be done, and so those lower priority but still important things don't get done for a while. It's nit-picking, certainly, but that's my chosen career. I'm paid to be anal.]

The boss is "cautiously optimistic." I am reasonably more optimistic. Yes, there will probably be things found. Yes, we have some issues that really cannot be completely remedied, although they can be mitigated. But IMO there is a high likelihood that any observations will be isolated incidents, or issues we know about and are already working to fix. I put us at about 50/50 for having something that we need to respond to officially.

I am not officially a part of that facility, but I did help start up its quality system, so I am on call. I will have a professional-looking tie with me tomorrow (as opposed to the ones with the Looney Tunes or Disney characters on them). It will be an interesting couple of days. Stay tuned.

[kayrharris]

Good luck! Hope it goes well.

[sunflower]

Good luck!

As an auditor, I always appreciate when people are helpful but not arrogant...optimistic is good but a "you won't find anything wrong here" attitude is not! So I think you are on the right track with "cautious optimism"! I am sure you will do great.

And don't forget the "I love a good audit" pin, if anything starts getting rough!!!

[gsabc]

Two auditors, in full uniform (similar to the Surgeon General's outfit). Our QA Manager says it's like being taken over by the Army. I suppose it's meant to be impressive and possibly intimidating. I think it's just pretentious. Still glad I'm not directly involved, though.

[Jocelyn Elders]

Two auditors, in full uniform (similar to the Surgeon General's outfit). Our QA Manager says it's like being taken over by the Army. I suppose it's meant to be impressive and possibly intimidating. I think it's just pretentious. Still glad I'm not directly involved, though.

Calm down, sir. We take these audits very seriously.

That's a nice button you're wearing. I'll trade you for a "Have you copped a feel today?" button I have left over from my administration....

[gsabc]

Two auditors, in full uniform (similar to the Surgeon General's outfit). Our QA Manager says it's like being taken over by the Army. I suppose it's meant to be impressive and possibly intimidating. I think it's just pretentious. Still glad I'm not directly involved, though.

Calm down, sir. We take these audits very seriously.

Yes, ma'am. Certainly, ma'am. That's a very nice uniform you're wearing, Mrs. Cleaver, er, General Sir, uh, Ma'am.

Rule #1: Never piss off an auditor.
Rule #2: The primary goal of the auditee is to get the auditor back out the door as soon as possible.

[gsabc]

Knew it was too good to be true. The inspector didn't realize that our other site is an aseptic manufacturing facility (the one where I am is not) and had not been inspected before. The two days now will morph into more like two weeks later on when they can schedule it. The two weeks is more typical, so it's not entirely unexpected, but we were hoping that this would be it.

I think they'll be giving us a quick once-over now, with the more intense scrutiny to be scheduled. The less they find this time around, then, the better.

[gsabc]

They are gone. They will be back around March, when they will (we hope) combine the normal, if it can be called such, initial facility inspection with our expected pre-approval inspection for our first commercial drug production. The combination would save everyone time and effort, so I don't hold out much hope. It's not like we hid the information about us being an aseptic manufacturing facility. All this agita for nothing.

There is still confusion about the device manufacturing establishment registrations for both sites, apparently stemming from a name change at the other site nearly two years ago. Why they can't look into their own records for this information, I don't know. I've spent/wasted nearly an hour today locating the darned things and creating and sending pdf files of them to the other facility.

This is one of those times when I question my career choice ...

[sunflower]

They are gone. They will be back around March, when they will (we hope) combine the normal, if it can be called such, initial facility inspection with our expected pre-approval inspection for our first commercial drug production. The combination would save everyone time and effort, so I don't hold out much hope. It's not like we hid the information about us being an aseptic manufacturing facility. All this agita for nothing.

There is still confusion about the device manufacturing establishment registrations for both sites, apparently stemming from a name change at the other site nearly two years ago. Why they can't look into their own records for this information, I don't know. I've spent/wasted nearly an hour today locating the darned things and creating and sending pdf files of them to the other facility.

This is one of those times when I question my career choice ...

Now you have a few months to stock up on "I love a good audit" merchandise...and to practice saying "we're really glad you're here" without laughing or puking.

[NellyLunatic1980]

Two auditors, in full uniform (similar to the Surgeon General's outfit). Our QA Manager says it's like being taken over by the Army. I suppose it's meant to be impressive and possibly intimidating. I think it's just pretentious. Still glad I'm not directly involved, though.

Calm down, sir. We take these audits very seriously.

That's a nice button you're wearing. I'll trade you for a "Have you copped a feel today?" button I have left over from my administration....

Where have you been all these years, Mrs. Elders?

Oh, wait... disregard that question. I know what you've been doing... the same thing that you said should be taught in school.