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

Future Events

Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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