2-Day Virtual Seminar 21 CFR Part 11 Compliance for SaaS/Cloud Applications

Live 2-Day Virtual Seminar 21 CFR Part 11 Compliance for SaaS/Cloud Applications When: Tuesday & Wednesday September 13 - Sep 14 , 2021 Duration- (8 Hours)

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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. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions.

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 allow quick and safe system evolution
Minimize the 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