Re: Any pharmaceutical tech writers out there?
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 www.21cfrpart11.com. 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!
Washington State Coordinator, Tombstone Project
Add photos to your e-mail with MSN 8. Get 2 months FREE*. http://join.msn.com/?page=features/featuredemail
Buy or upgrade to RoboHelp X3 today and receive the WebHelp
Merge Module for FREE ($299 value). RoboHelp X3's all-new
features include conditional text, completely re-engineered
printed documentation output, Context-sensitive Help Toolkit,
single-source layouts, and more!
Order online today at http://www.ehelp.com/techwr-l
You are currently subscribed to techwr-l as:
archive -at- raycomm -dot- com
To unsubscribe send a blank email to leave-techwr-l-obscured -at- lists -dot- raycomm -dot- com
Send administrative questions to ejray -at- raycomm -dot- com -dot- Visit
http://www.raycomm.com/techwhirl/ for more resources and info.
Previous by Author:
Re: TW -> QA
Next by Author: Re: TECHWR-L 10-year Praise-a-Thon
Previous by Thread: Re: Any pharmaceutical tech writers out there? - THANKS
Next by Thread: RE: Any pharmaceutical tech writers out there?
Visit TechWhirl's Other Sites