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

Live Seminar- 2-Day Virtual Seminar 21 CFR Part 11 Compliance for SaaS/Cloud Applications When: Tuesday & Wednesday Jun 2 - Jun 3 , 2021 DAY 01 & DAY 02 (9:00 AM - 3:00 PM PDT)

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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.
Nearly every computerized system used in laboratory, clinical, manufacturing settings, and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
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