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    Aug 31, 2021

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

    in Webinars

    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


    Register soon because space is limited.

    We hope you’re able to join us!


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