2020 - 21 CFR Part 11 and QMS Software Risk-Based Implementation

U.S. FDA's expectations / requirements
Recent Data Integrity and Cybersecurity regulatory requirements
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
The development of a 21-year long, field-tested FDA "Model"
Basic development, implementation, use, and decommissioning expectations
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Applicable standards and industry-recommended Guidelines