Re: Pharmaceutical industry buzzwords

Subject: Re: Pharmaceutical industry buzzwords
From: Jill Shindelman <jill_shindelman -at- yahoo -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Wed, 6 Feb 2002 06:27:31 -0800 (PST)

--- Justin Cascio <justin-paul -dot- geo -at- yahoo -dot- com> wrote:
> I'm finding here in New Jersey that many of the
> technical writing jobs
> available are in the pharmaceutical industry, and
> have requirements like
> "The candidate MUST have Validation experience (IQ,
> OQ, PQ)," "understanding
> of FDA regulations and guidelines a must," and
> "Candidate must have thorough
> knowledge of regulatory requirements (CFR)." I would
> be very grateful if any
> of you with pharmaceutical experience or who know
> about these "buzzwords"
> could direct me to where I might learn about these
> regulations. I don't have
> any experience with these regs, and want to
> familiarize myself with them so
> I might apply for one of these jobs and know
> something about them in an
> interview.

Justin -

The terms you refer to are used by the FDA, and the
pharmaceutical industry takes FDA "recommendations"
very seriously, to say the least. The FDA just issued
a new version of their "General Principles of Software
Validation; Final Guidance for Industry and Staff"
last month. You can download a copy in PDF format by
following this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx.cfm?alpha=s

and scrolling down to the "Software" section.

This document defines, among other things, IQ
(Installation Qualification), OQ (Operational
Qualification) and PQ (Performance Qualification).

Judging by the volume of documentation the FDA seems
to require of "industry and staff" who follow these
guidelines, there is a lot of potential work here for
technical writers!

Jill Shindelman


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References:
Pharmaceutical industry buzzwords: From: Justin Cascio

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