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2023 - 21 CFR Part 11 Compliance for SaaS/Cloud Applications

Date2023-02-01 - 2023-02-02


VenueSan Diego, CA, USA - United States USA - United States

KeywordsCsv seminar; Computer systems validation


Topics/Call fo Papers

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

Last modified: 2022-12-07 00:09:42