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  • FDA Medical Device Quality System Inspection Technique
    (QSIT) Inspections to 21 CFR 820

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Jun 13, 2013 10:00 AM
  • End Time:
  • Thursday - Jun 13, 2013 11:15 AM
  • Location:
  • Online
  • This webinar on medical device inspections will explain how the FDA interprets and understands the Quality System Inspectional Technique (QSIT) and what you can do to ensure your quality system is free from deficiencies prior to an FDA inspection.

    Why Should You Attend:

    This webinar will completely address the FDA requirements as contained within 21 CFR 820 for Medical Devices and their interpretation on the manner in which FDA looks at these regulations with respect to QSIT during a regulatory inspection. Additionally, internal auditing systems can be noted to lack the ability to identify Quality System Regulation deficiencies prior to FDA arriving for an inspection.

    Therefore, if these GMP deficiencies are not known to or uncovered by the internal audit function, FDA will be very happy to point out these problems via an FDA-483, Inspectional Observations, and ultimately a Warning Letter.

    This training will help medical device manufacturers gain critical internal knowledge of what a healthy Quality System is to be and the manner in which to maintain such a system.

    Learning Objectives:

    The objective of this session is to gain an understanding of the manner in which FDA inspects medical device manufacturers and their interpretation of compliance to 21 CFR 820.

    Areas Covered in the Webinar:

    - 21 CFR 820 basic ideas to a healthy Quality System
    - FDA inspectional understanding of QSIT (Quality System Inspectional Technique)
    - Management Controls and the QSIT approach to 21 CFR 820
    - Design Controls and the QSIT approach to 21 CFR 820
    - Corrective and Preventive Actions and the QSIT approach to 21 CFR 820
    - Production and Process Controls and the QSIT approach to 21 CFR 820
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