FDA`s 21 CFR Part 11 Add-on Inspections 2019

Topics

• 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

Who should Attend

• 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