Validation and Use of Excel Spreadsheets in FDA Regulated Environments

The Validation and Use of Excel Spreadsheets in FDA Regulated Environments is a webinar that covers topics such as:

  • Learning from FDA warning letters related to spreadsheets
  • FDA and other agency`s requirements for spreadsheet validation - What do inspectors ask and what documents should be available
  • Validation during design, development, installation and on-going use
  • How to design spreadsheets for Part 11/GxP/Annex 11 compliance
  • Dealing with standard Excel functions: Recommendations from GAMP5
  • When, what and how much to test?
  • How to apply risk based validation to spreadsheet applications
  • How to ensure and validate spreadsheet integrity and security for Part 11?
  • How FDA is using spreadsheets
  • Validation of `single use` spreadsheet applications
  • Examples from manufacturing, laboratories and offices
  • How to document planning, specifications, installation, testing and changes

The Validation and Use of Excel Spreadsheets in FDA Regulated Environments is intended for attendees from:

  • Contract laboratories
  • Pharmaceutical and medical device industry
  • Validation specialists
  • All developers and users of spreadsheet applications
  • Production and lab managers
  • QA/QC managers and personnel
  • Training department
  • Regulatory affairs
  • Consultants
  • Documentation department

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