Live Webinar: 21 CFR Part 11 and QMS Software Risk-Based Implementation When: Wednesday August 18, 2021 - 01:00 PM Duration: 60 Minutes.
CGMP-compliant companies must develop / implement formal software controls and usage, starting with proper verification and validation methods. This is an important consideration for a company’s Quality Management System (QMS) and must consider applicable elements of electronic records / signatures / Part 11. The US FDA recently added data integrity and cybersecurity to these requirements. These activities must be properly documented.
Areas Covered in the Webinar:
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