Root Cause- Is/ Is Not Tool


Combination Products

DATE: Tuesday May 1, 2018

TIME: 10 am PST/ 1 pm EST

PRESENTER: Collis Laton Floyd

DURATION: One Hour Presentation

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Combination products are a key part of the landscape of the Medical Device, Pharmaceutical and Biologics industries today.  New approaches to treatment methods and new manufacturing abilities allow more ways to deliver product to patients.  The FDA has developed the Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products to help us.

This webinar focuses on key highlights of the guidance document along with considerations for how to classify for regulatory approval and postmarketing safety reporting requirements.  This webinar is geared toward those who actively work in combination product development, manufacture, quality assurance, project management or other key roles. 

Combination Products


  • Provide an overview of the combination products guidance

  • Define combination products

  • Discuss regulatory  paths for combination products

  • Examine postmarketing safety reporting requirements for combination products






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