How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR 2018 is a conference dedicated to the specific requirements associated with local and SaaS/cloud hosting solutions.
Topics
How to use electronic records and electronic signatures to maximize productivity
Reducing costs, usually by two-thirds, for compliance with electronic records
Avoiding 483 and Warning Letters
What is expected in Part 11 and Annex 11 inspections so you are prepared
Responsibilities and liabilities when using SaaS/cloud
The responsibilities and specific duties of your staff including IT and QA
How to perform risk-based Computer System Validation using fill-in-the-blank templates
How HIPAA expands Part 11 compliance
"Right size" change control methods that allows quick and safe system evolution
How to select resources and manage validation projects
How to reduce testing time and write test cases that trace to elements of risk management
Minimizing validation documentation to reduce costs without increasing regulatory or business risk
How to buy COTS software and qualify vendors
How to comply with the requirements for data privacy
Protecting intellectual property and keep electronic records safe
Past Events
How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR 2018 - 05-06 Dec 2018, DoubleTree by Hilton Hotel San Diego Downtown, California, United States (80463)
Important
Please, check "How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR" official website for possible changes, before making any traveling arrangements
