HPLC training module to meet FDA standards

[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?

[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

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.

[DR]

If you really want to be intimidated, start looking around here: http://www.fda.gov/ora/science%5Fref/lm/

[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.

[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...

[tom jupille]

DR is right. It only applies to you if you work for the FDA.

[DR]

I'm not one to cross post (normally), but John - have you seen what Alfred88 found?

[John]

All I get from that link is a forum index. What specifically should I be looking at?
J

[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!