21 CFR Part 11/Annex 11 compliance for software validation and SaaS 2016

Topics

• Avoid 483 and Warning Letters
• What is expected in Part 11 and Annex 11 inspections
• Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
• How to buy COTS software and qualify vendors
• How to select resources and manage validation projects
• Requirements for local, SaaS, and cloud hosting
• Minimize the validation documentation to reduce costs without increasing regulatory or business risk
• "Right size" change control methods that allows quick and safe system evolution
• Protect intellectual property and keep electronic records safe

Who should Attend

• QA/ QC
• Regulatory Affairs
• Software Managers
• IT/IS
• Software vendors and suppliers
• Project Managers