IT Infrastructure Qualification
Topics:
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FDA's latest hot topic - IT Infrastructure Qualification
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Validation is for intended use
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How to determine critical parameters such as disk, network, memory, and processor
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Documented Standard Operating Procedures you must have and follow
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Security, data integrity, audit trails
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21 CFR Part 11 requirements and compliance
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Some recent warning letters and what may have prevented them
As you know, validation is for intended use. We validate applications, not the operating systems and other infrastructure they run on. But clearly, the infrastructure must be documented, tested, and controlled in order for the application to be validated. Does this mean IT has to understand the application and the application owner has to understand the server infrastructure? Not necessarily. During this free webinar, Steve Vinson will outline an approach many companies are using to leverage the strengths of both IT and application owners.
We will discuss the promise and potential pitfalls of the IT Infrastructure Qualification approach. This will be a high level overview - an hour is not enough to cover much detail. Please come prepared with questions and input so that we can plan a follow-up webinar if a deep dive is needed.
Webinar Date & Time:
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October 26, 2007 |
12 P.M. - 1 P.M. EDT |
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There is no cost, but each registrant will receive a unique link to access each session. Please call us at 317-275-2870 if you have any questions.