How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud 2018 is a course dedicated to the specific requirements associated with local and SaaS/cloud hosting solutions.
Topics
Avoiding 483 and Warning Letters
What is expected in 21 CFR Part 11 and Annex 11 inspections
Implementing a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
How to buy COTS software and qualify vendors
How to select resources and manage validation projects
Requirements for local, SaaS, and cloud hosting
Minimizing the validation documentation to reduce costs without increasing regulatory or business risk
"Right size" change control methods that allows quick and safe system evolution
Protecting intellectual property and keep electronic records safe
Writing test cases that trace to elements of risk management
Past Events
How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud 2018 - 11 Sep 2018, Four Points by Sheraton Boston Logan Airport Revere, Massachusetts, United States (77730)
Important
Please, check "How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaSCloud" official website for possible changes, before making any traveling arrangements
Event Categories
Education: Education Technologies & Methods, Higher education, Training
