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  • Ensure Compliance to FDA's Design Control Requirements by
    using Requirements Management Techniques

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Feb 28, 2013 10:00 AM
  • End Time:
  • Thursday - Feb 28, 2013 11:15 AM
  • Location:
  • Online
  • This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's Design Control requirements.

    Why Should You Attend:

    With headlines reading "Device firm cited for faulty design input requirements, not validating device design." it is important to understand the FDA regulations related to design inputs and how they impact other design control elements. Requirements Management is a CMMi level 2 Key Process Area (KPA) which involves managing versions of requirements and the relationship between requirements and the project deliverables. Using this model as a best practice, can result in a more robust design control process and minimize FDA observations.

    There is a wide variation of how the medical device industry manages requirements. This presentation will cover a requirements management approach consistent with the CMMi Requirements Management KPA, that helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements. Specific Goals to be reviewed are: Obtaining an Understanding of Requirements, Obtain Commitment to the Requirements, Manage Requirements Changes, Maintain Bidirectional Traceability of Requirements and identify Inconsistencies Between Project Work and Requirements.
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