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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: US$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
Speaker Profile
Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.


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