RE: FDA documentation experience?

["Dan Goldstein" <DGoldstein -at- riverainmedical -dot- com>]

Hi Chris,

Hope the interview goes great this morning!

The best courses I've seen are the ones run by AAMI (Google 'em).
They're pricier than your audio seminar, but they're worth it, too. Most
of the attendees are there on their companies' tab, with a scattering of
independent contractors who can deduct the seminar as a business
expense.

FDA personnel are usually among the attendees and sometimes among the
presenters. If you want to learn the regulations, there's nothing like
having someone stand up and say, "When I wrote that part of the
regulation, my intention was..." or "When I review your next regulatory
submission, I'll be looking for..."

Please post and let us know how it goes! If you get the job, there are
other medical device tech writers on TECHWR-L who can help you with your
questions as you go along.

Best of luck,

Dan

> -----Original Message-----
> From: Chris Morton
> Sent: Friday, September 05, 2008 8:28 PM
> To: techwr-l -at- lists -dot- techwr-l -dot- com
> Subject: FDA documentation experience?
> 
> Have any of you ever had a position requiring FDA 
> documentation compliance? I know nothing about 
> the topic and have an interview scheduled this 
> coming Monday morning. The company develops and 
> sells medical equipment.
> 
> The best I could find by Googling, it would 
> appear, is this:
> http://www.labcompliance.com/seminars/audio181/default.aspx. 
> I obviously don't have time to complete the 
> seminar before my interview, but I think it'll 
> help to mention that I researched this and am 
> interested in pursuing it if I get hired. At $349, 
> it's also a bit pricey, so I don't want to commit 
> to it if I don't get hired.
> 
> I am curious to learn from you what experience 
> you've had in regard to FDA documentation; any 
> ammo I can collect could possibly tip the scale 
> in my favor.
> 

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