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

Instructor: Jeff Kasoff
Product ID: 701143
  • Duration: 60 Min
This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Aug-2013

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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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Seminars by Ex-FDA Officials

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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