Live Webinar

How FDA Evaluates Your Quality Management System

insert_invitation Friday, 26th January, 2018
access_time 01:00 PM EST | 10:30 AM PST
timelapse 60 Min with 15 Min QnA of Q and A

Short Abstract

Once your company has successfully navigated the U.S. device clearance process, a Quality Management System (“QMS”) needs to be implemented before you can start marketing your product. Your QMS must contain all the requirements of FDA’s Quality System Regulations (“QSR”).

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

The presentation will cover the following areas:

  • Introduction to FDA Regulations
  • Overview of Quality System Regulations (“QSR”)
  • How FDA Evaluates Your Quality Management System (“QMS”)
  • Most Inclusive Requirement: Document Control
  • Most Critical FDA Non-conformances
  • Most Common FDA Non-conformances

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