SOURCE: Xtalks

Xtalks Webinars

September 18, 2015 07:00 ET

Colorants in Devices: Successfully Integrated Strategies Towards Regulatory Approval, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 18, 2015) - Join industry expert, John Iannone, Program Manager/Technical Specialist for Extractables/Leachables & Special Studies at Toxikon Corporation, for an informative session that will discuss the regulation of colorants in medical devices and present solutions to many of these challenges. The live broadcast takes place on Tuesday, October 6, 2015 at 11:00am EDT (4pm BST/UK GMT +1).

A challenge common to all medical device manufacturers is conducting a regulatory submission which is both effective and efficient. Successful submissions with devices that utilize colorants are less likely to go off without a hitch. What exactly is the perspective of the FDA with regard to Colorants in Medical Devices? What testing is a Medical Device Manufacturer expected to conduct to support the use of a colorant in a medical device? What about the Colorant Manufacture's Master File with the FDA… will that address testing requirements?

The presentation will help viewers prepare for the attainment of a successful regulatory submission by providing answers to many of these inquiries and more. Discussion topics will include:

  • What you need to know about USP Class VI(6) vs. ISO 10993
  • Biocompatibility Testing considerations of colorized devices
  • What information a Device Manufacture can obtain from the colorant manufacturer?
  • Chemical Characterization of Materials as it applies to proprietary colorants
  • Toxicology Risk Assessments of Colorized Devices
  • FDA approved color additives for Medical Devices

To learn more about this event visit: Colorants in Devices: Successfully Integrated Strategies towards Regulatory Approval

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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