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FDA 21 CFR Part 11 for techies

FDA 21 CFR Part 11 for techies

Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Technical implementation personnel,Technical maintenance personnel,System designers and integrators,System owners -responsible for keeping individual systems in validation,QA / QC managers, executives and personnel,Consultants,IT / IS managers and personnel
Start Date of Conference:: 12-17-2009
End Date of Conference: 12-17-2009
Description of Conference: This 21 CFR Part 11 webinar/training will discuss on the technical details required by technical personnel to understand, communicate and implement part 11 compliance in to computer systems regulated by FDA.

Areas Covered in the seminar:

* Outline of FDA regulatory scheme.
* Review of FDA software validation regulations.
* Why 21 CFR part 11 compliance is good business.
* Review part 11 regulation.
* Future of part 11 enforcement.
* The biggest 21 CFR part 11 technical problems.
* Communicating part 11 technical details with business, validation and software quality assurance.

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