The Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2019 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 2019 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