Live Webinar - "21 CFR Part 11 and QMS Software Risk-Based Implementation"

Live Webinar: 21 CFR Part 11 and QMS Software Risk-Based Implementation When: Friday September 3, 2021 - 03:00 PM Duration: 60 Minutes.

Register Now     

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. Software / firmware design, development, testing / verification and validation, implementation and usage, is difficult to structure, manage, document and control, especially in the QMS with Pt. 11. For many companies the subject can be intimidating.

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