Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. 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... Read more

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. 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