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HPLC training module to meet FDA standards

Posted: Wed Mar 28, 2007 9:21 pm
by rwk27834
I would consider this question to be an HPLC issue and a regulatory issue. I would like to develop an HPLC training module for the analysts at my company. I would like it to be such that if an analyst was trained on it, the FDA would be satisfied that such analyst would be sufficiently trained on HPLC. Any suggestions?

Posted: Thu Mar 29, 2007 2:33 am
by tom jupille
First of all, most FDA issues with training relate to documentation and paperwork rather than content.

That said, I know this is going to sound self-serving, but:

Putting together a good training program is a tremendous amount of effort. I typically plan on about 1 day of effort for each hour of presentation time -- and that's with a 20-year backlog of slides, figures, chromatograms, etc. to draw on. Unless you will be doing this on your own time (i.e., for free), it's far more cost-effective to have your people trained by someone who has done it before and can therefore spread that development effort over a larger base. Someone like, ahem, LC Resources:
http://www.lcresources.com :shock:

If you don't want to go that route, there are excellent computer-based training programs available that would allow your analysts to work through the material at their own pace. Check out Academy-Savant for some good ones:
http://www.academysavant.com/

Another cost-effective alternative is audio or web seminars. John Dolan and I will be doing a series on LC Troubleshooting for GMP Training Systems:
http://www.gmptrainingsystems.com
LC-GC Magazine also sponsors "webinars", as do many of the instrument companies.

As far as FDA being satisfied, I can only speak directly about our own courses:
- the FDA sends their people to our courses,
- we've done literally hundreds of courses for pharmaceutical companies over the years, and have never had anyone complain about them not being good enough for FDA.

Posted: Thu Mar 29, 2007 2:45 pm
by DR
If you really want to be intimidated, start looking around here: http://www.fda.gov/ora/science%5Fref/lm/

Posted: Mon Apr 09, 2007 6:35 pm
by John
If you really want to be intimidated, start looking around here: http://www.fda.gov/ora/science%5Fref/lm/
This is comprehensive. Are all US pharmaceutical labs legally bound to this manual? I have never heard of this document referenced in audits.

Posted: Mon Apr 09, 2007 7:21 pm
by DR
Are all US pharmaceutical labs legally bound to this manual? I have never heard of this document referenced in audits.
In a word, no (IMHO). But it delivers some insight as to where ORA is coming from...

Posted: Mon Apr 09, 2007 11:46 pm
by tom jupille
DR is right. It only applies to you if you work for the FDA.

Posted: Tue Apr 10, 2007 1:49 pm
by DR
I'm not one to cross post (normally), but John - have you seen what Alfred88 found?

Posted: Tue Apr 10, 2007 8:16 pm
by John
All I get from that link is a forum index. What specifically should I be looking at?
J

Posted: Tue Apr 10, 2007 10:43 pm
by Bryan Evans
I can only tell you from experience from how we used to do things.
I worked in a regulated pharmaceutical environment for 7 yrs - doing QC/method development/validation. I was also in charge of training our new employees in our lab on HPLC - and also did some internal auditing on the side (when I had time). We withstood countless IND/NDA audits, and never had a problem.

We also had the luxury of having a terrific QA program in place - so the system of protocol approvals, SOPs, signature approvals, ect., was all very well done. This is probably one of the most important items - FDA places a big emphasis on auditing systems rather than individual items (i.e. risk assessment).

Anyways - we would have new chemists run a caffeine calibration test on our HPLCs. They would make up the linear stds themselves, and have to pass % recovery specifications before being "trained" on HPLC. We made it a point not to train them on samples - obviously - because if it failed, now the samples would be in question. And yes - if the HPLC training failed, the LC would be in question - but we had a nice HPLC maintenance/calibration SOP, along with strict system suit requirements for every run - so that if the instruments did fail - there was plenty of documentation to support that they were fine when doing sample analysis (though they never failed during training).

All of Tom's suggestions were great - just telling you how we did things!