Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to control, validate and use Excel® the requirements can be met. Attendees of this seminar will get all details on how requirements can be met
Areas Covered in the Session:
FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
Learning from FDA warning letters related to spreadsheets
How to design spreadsheets for Part 11/GxP/Annex 11 compliance
Validation during design, development, installation and on-going use
When, what and how much to test?
Dealing with standard Excel functions: Recommendations from GAMP5
How to ensure and validate spreadsheet integrity and security for Part 11?
How to apply risk based validation to spreadsheet applications
Validation of 'single use' spreadsheet applications.
How FDA is using spreadsheets
How to document planning, specifications, installation, testing and changes
Examples from manufacturing, laboratories and offices
For Easy Implementation, Attendees Will Receive:
User Manual with Excel functions that help to comply with FDA requirements
SOP: Validation of spreadsheet applications
SOP: Development and use of spreadsheets in regulated environments
Gap analysis/checklist for Macros and Spreadsheet applications
- Pharmaceutical and medical device industry
- Contract laboratories
- All developers and users of spreadsheet applications
- Validation specialists
- QA/QC managers and personnel
- Production and lab managers
- Regulatory affairs
- Training department
- Documentation department