FDA`s 21 CFR Part 11 Add-on Inspections 2019 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 2019 is intended for:
- Middle management
- Senior management
- Engineering
- R&D
- QA / RA
- Software
- Operations
- Manufacturing
- CGMP instructors
- Consultants
- All personnel especially involved in product, process, validations, cGMP responsibilities
