21cfrpart11doc
21cfrpart11doc
| Forum role | Member since | Last activity | Topics created | Replies created |
|---|---|---|---|---|
| Member | Sep 5, 2007 (18 years) |
- | 1 | 7 |
- Forum role
- Member
- Member since
Sep 5, 2007 (18 years)
- Last activity
- -
- Topics created
- 1
- Replies created
- 7
Bio
I've worked in the FDA-regulated pharma indusry for 20 years. My experience expands Medical Device, Pharmaceutical, and Biotech. I enjoy the Biotech industry the most because it is fairly new to the pharma environment and lends itself well to creativity and out of the box thinking. My education is in technical writing and editing, my training and experience are in Quality Software Engineering and Validation, and I specialize in compliance with 21 CFR Part 11 for Electronic Records and Electronic Signatures.
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