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

Why You Should Attend:

Your  company's marketing department 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. Sometimes mislabeling and aggressive labeling can put you in to trouble.

This FDA labeling webinar will provide a comprehensive knowledge of labeling development and subsequent control. The updated FDA requirements and expectations regarding labeling contents will be covered. We will discuss the recommended best practices  and how to follow it to assure substantial compliance. 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 compliance.

Areas Covered in the seminar:

• 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:

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

• Regulatory Affairs management
• Document Control (label generation) professionals
• Design Control professionals
• Quality Assurance professionals
• Sales/marketing management

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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