21 CFR Part 11 compliance for software validation and SaaS/Cloud 2019 is a seminar that covers topics such as:
- Avoid 483 and Warning Letters
- What is expected in Part 11 and Annex 11 inspections
- 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
- Minimize the validation documentation to reduce costs without increasing regulatory or business risk
- "Right size" change control methods that allows quick and safe system evolution
- Protect intellectual property and keep electronic records safe
- Test cases that trace to elements of risk management
21 CFR Part 11 compliance for software validation and SaaS/Cloud 2019 brings together attendees from:
- All GxP system users
- QA, IT, management
