Conference Description:

Course Objectives:
• Understand what is expected in 21 CFR Part 11 and Annex 11 inspections
• Avoid 483 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