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Spreadsheet Validation: Understanding and satisfying FDA requirements

Aug 08,2012 - Aug 08,2012
Online Event, California, United States


This Spreadsheet validation training explores strategies for recognizing when validation is required, how to achieve compliance and what documentation needs to be generated and maintained.


Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.

Areas Covered in the seminar:

  • Review of current FDA posture towards spreadsheets.
  • Review the relationship between "validation" and "part 11 compliance".
  • How do I determine which spreadsheets require validation?
  • Which spreadsheets are required to be compliant to 21 CFR Part 11 regulation?
  • Technical issues discussion.
  • Practical tips on gaining control over spreadsheets.
  • Practical tips on spreadsheet validation.

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Event Profile

Sponsors: ComplianceOnline
Speakers: Alfonso Fuller
Attendees: Management responsible for operational and quality systems ("system owners"),QA Directors, Managers and personnel,IT / IS managers and personnel

Contact Details

Contact person: ComplianceOnline
Event website:
Phone: +1-650-620-3915
Fax: +1-650-963-2556

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