FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes

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					GlobalCompliancePanel                                               Your Gateway to Regulatory Compliance

Live Webinar on

FDA Requirements for Device Labeling: Development,
Contents, Distribution, and Changes

Date: Thursday, December 5, 2013                                    Time: 10:00 AM PST | 01:00 PM EST

   Duration:    60 Minutes
   Location:    Online                                                         Register Now
 Instructor:    Jeff Kasoff

Overview:
Marketing wants to entice customers to buy your product instead of your competitor's! A common
method is to make the labeling as eye-catching as possible.

Be careful! You need to know what information can (and more importantly) CANNOT be present on
the labeling. This presentation provides comprehensive knowledge of labeling development and
subsequent control. FDA requirements and expectations regarding labeling contents will be
covered, as will recommended practices to assure substantial compliance.


Areas covered in the session:

    l   Prescription Device Labeling
    l   Misbranding, False Or Misleading Labeling
    l   Approval
    l   Issuance
    l   Label Integrity
    l   Label Inspection
    l   Contractor-Produced Labels As A Linkage With Purchasing Controls
    l   Retention
    l   When a labeling change requires a new submission



Who Will Benefit:                                    About Speaker

                                                     Jeff Kasoff
    l   Regulatory Affairs management
                                                     Director of Regulatory Affairs, Life-Tech, Inc
    l   Document Control (label generation)          Jeff Kasoff RAC, CQM, is the Director of Quality at
        professionals                                Medivators, a leading manufacturer of consumables
                                                     and instrumentation in the endoscopy field. Among his
    l   Design Control professionals
                                                     responsibilities is oversight of the document control
    l   Quality Assurance professionals              system. In his 20+ years of Quality and Regulatory
    l   Sales/marketing management                   management,   ...more


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