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

Global CompliancePanel
Global CompliancePanel
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
Instructor Jeff Kasoff
Product Id 600045

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

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



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