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18Aug
Live Webinar- "21 CFR Part 11 and QMS Software Risk-Based Implementation"
1:00 PM - 2:00 PM New York
Date: August 18, 2021 to August 18, 2021
Where: New York, New York,, New York County, New York, United States, 10018
Phone: N/A
Event Type: Other
Ticket Price: N/A
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
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