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Transforming to a Risk-Based Approach to Computer System Validation 
Framework • SOPs • Templates
 
Duration: 1 hour

Speaker: Steven A. Vinson, PMP
 
Topics:
  • Procedures, guidelines and templates for measuring risk
  • How do we include safety requirements based on risk?
  • Procedures, guidelines and templates for scaling the validation effort based on risk
  • How do you document your approach so that it is consistent from project to project?
  • How do we defend our approach to auditors?
  • What does all this buy me?

This is an intermediate to advanced webinar for those who know the basics and are convinced that a risk-based approach is the right thing to do.  The professionals know what it is, but their organizations may be struggling with how to transform to a risk based approach to Computer System Validation (CSV).  Steve will cover briefly what risk-based CSV is and why it is a good idea, so that everyone is on the same page.  He will cover in depth how to write procedures, guidelines, and templates that allow you to apply the principles consistently and allow you to confidently defend your approach.  This presentation will wrap up with the benefits and potential pitfalls encountered while transforming to a risk-based approach to CSV.  The last 15 minutes of this session will be open for Q&A.
 
Webinar Date & Time:

July 19, 2007 
12 P.M. - 1 P.M. EDT
Done
August 3, 2007
3 P.M. - 4 P. M. EDT
Done

There is no cost, but space is limited to only 25 registrations per session. If multiple people from your organization would like to view this webinar together, we recommend that only one person sign-up. Please call us at 317-275-2870 if you have any questions. 
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