FDA s 21 CFR Part 11 Add-on Inspections 2017 is a webinar that covers topics such as:
- The proven V&V 11-element "model" – useful for all software V&V
- 21 CFR Part 11, Electronic Records / Electronic Signatures – What it is and what it isn’t?
- "Risk Based" – what it means in SW V&V and how it should be used
- Developing test cases / scripts from Part 11
- Insights on Cloud issues and Agile issues
- Why Part 11 violations seldom show up directly on 483’s, but are there nonetheless
FDA s 21 CFR Part 11 Add-on Inspections 2017 is intended for:
- Quality Engineers
- Quality Managers
- GxP
- Small business owners
- Consultants
- Regulatory Affairs professionals
- IT VPs
- Quality VPs
- CEOs
- Regulatory VP
