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.
How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR 2018 covers topics such as:
- 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
