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