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

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labeling.

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:
  • Prescription Device Labeling
  • Misbranding, False Or Misleading Labeling
  • Approval
  • Issuance
  • Label Integrity
  • Label Inspection
  • Contractor-Produced Labels As A Linkage With Purchasing Controls
  • Retention
  • When a labeling change requires a new submission
Who Will Benefit:
  • Regulatory Affairs management
  • Document Control (label generation) professionals
  • Design Control professionals
  • Quality Assurance professionals
  • Sales/marketing management
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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