Conference & Events
Event Details
FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes - Webinar By GlobalCompliancePanel
Overview: 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.
Date: 16 May 2012 10:00 - 11:30
Event Subject(s):
Biosciences
Education
General
Venue
Online Training
1000 N West Street
Suite 1200
Wilmington,DE
19801
United States of America
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Organiser Information
Organiser(s): GlobalCompliancePanel
Contact for Event Information
Name : Online Training
United States of America
Tel:
800-447-9407
Fax:
302-288-6884
Email:
webinars@globalcompliancepanel.com
Contact Useful link:
http://www.globalcompliancepanel.com
Additional Information
Speaker Information:
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.
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Other information:
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: 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
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
