Computer system validation - Reduce Costs and Avoid 483s

Learning objectives :

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

​Training link (Site link) : Link