Re: Any pharmaceutical tech writers out there?

Subject: Re: Any pharmaceutical tech writers out there?
From: "Diane Evans" <diane_evans -at- hotmail -dot- com>
To: "TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Wed, 12 Feb 2003 08:19:46 -0800

What are they REALLY looking for when they always say, "Need
validation/21 CFR Part 11/cGMP" etc.?

GMP means Good Manufacturing Practices; GLP means Good Laboratory Practices; GCP means Good Clinical Practices; GxP means any combination of these.

How does a person whose main skill is in
the technical writing, not the domain knowledge, convey his value to
pharmaceuticals? How does he get the experience, or at least some basic training?

You can learn all there is to know about 21 CFR Part 11 at They offer free webinars, as well as seminars in various parts of the country. There is also a link from this site to a yahoo group on 21 CFR Part 11.

How did I get into this? By luck. I am working for a small biotech firm that is a "wholly owned subsidiary of Merck Pharmaceuticals." The lab needed someone to do documentation; before being hired, I had never even heard of 21 CFR Part 11. I was hired for my knowledge of documentation and my ability to come where "no man has gone before" and set up a complete documentation life cycle and write documents for the software we are building here.

Good luck. There is a lot of growth in this industry. I love my job!

Diane Evans
Technical Writer

Washington State Coordinator, Tombstone Project

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