Learning Objectives:

• Reduce costs, usually by two-thirds, for compliance with electronic records
• Learn how to use electronic records and electronic signatures to maximize productivity
• Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
• Avoid 483 and Warning Letters
• Understand the responsibilities and specific duties of your staff including IT and QA
• Understand your responsibilities and liabilities when using SaaS/cloud
• Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
• How to select resources and manage validation projects
• "Right size" change control methods that allows quick and safe system evolution
• Minimize validation documentation to reduce costs without increasing regulatory or business risk
• Learn how to reduce testing time and write test cases that trace to elements of risk management
• Learn how to comply with the requirements for data privacy
• Learn how to buy COTS software and qualify vendors
• Protect intellectual property and keep electronic records safe