Validation and Use of Excel Spreadsheets in FDA Regulated Environments

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

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

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

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

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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