FDA Validation 2012 - Spreadsheet Validation: Understanding and satisfying FDA requirements
Date2012-08-08
Deadline2012-08-08
VenuePalo Alto, USA - United States
KeywordsFDA; spreadsheets; validation; part 11 compliance; 21 CFR; spreadsheet validation
Topics/Call fo Papers
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.
Other CFPs
- GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters
- FDA Software Validation Self-Check ? plan an effective Internal Audit program
- Pharmaceutical Water System Use & Monitoring
- Equipment Calibration in FDA QSR ? Regulations and Warning Letters
- Acceptance Activities in FDA QSR ? Regulations and Warning Letters
Last modified: 2012-03-06 18:54:09