[TheForge] Thanks for the good wishes. OT & Long

[Bruce Freeman]

Gang,

Thanks for all the good wishes I've received in
response to my posting of my retirement and job
change.  I can't thank each of you individually, so
please accept this general thanks.

In the few days it dawned on me I may have
inadvertently shafted my ex-boss a bit.  (And you can
imagine how broken up I am about that!)  It's a neat
little tale of just deserts:

A couple years ago I developed a "method of analysis"
(a procedure for analyzing a particular drug product)
for product "O".  I had just got it working reasonably
well and was about to optimize it - mainly, reducing
the time each sample took to analyze it - when my boss
said "no" - it was time to validate it  - as is.  I
pointed out the difficulty of using a method that took
40 minutes per sample, but he put his foot down,
saying there'd never be all that many samples.  

So I validated it as a 40-minute method.  Now, the
thing about validation is that that and all subsequent
work get filed with the FDA.  You CAN change things
after that, but it's a bitch to do.  So pretty much
when a method is validated, it's set in stone.

Now my next major assignment was to develop the same
method for a different sample, "P".  Since most of the
work was already done, and since this time it was
clear that there WOULD be a lot of samples, my boss
agreed to my reducing the time of analysis.  I was
constrained, however, by wanting to make the new
method compatable in as many ways as possible with the
old.  I succeeded at that, but could only cut the time
to 20 minutes.  (Given free hand, it would have been
possible to cut it to 10 minutes, and possibly even
shorter.)  This short analysis time helped a lot
during the validation.

Well, in the intervening years, a stability study had
been started for product "O".  A couple months ago,
the first samples from this study came  into the
analytical lab - relatively few samples that time -
and there were problems getting the work done in a
timely manner.  This included other assays besides
mine, but the 40-minute cycle time was definately a
hindrance.

It occurred to me that the next set of samples are due
in January, and they were already scrambling to figure
out how to do them all BEFORE I left.  Guess what
drudge work I just got out of doing!

Best wishes to all for the holidays,

Bruce


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