21 CFR Part 11/Annex 11 compliance for software validation and SaaS 2016 is a course that covers topics such as:
- Avoid 483 and Warning Letters
- What is expected in Part 11 and Annex 11 inspections
- Implement 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
21 CFR Part 11/Annex 11 compliance for software validation and SaaS 2016 is intended for:
- QA/ QC
- Regulatory Affairs
- Software Managers
- IT/IS
- Software vendors and suppliers
- Project Managers