FDA Guidance for Medical Device Recalls
Virtual Boot Camp
Explore the Full Scope of Device Recalls — And Stay Ahead of the Game
Presented By: Angela Bazigos
Pre-recorded (180 Minutes)
Overview :

The number of medical device recalls has been climbing steadily—from just over 2,300 in 2013 to more than 3,200 in 2017. But not all recalls are created equally. A voluntary manufacturer recall has far different ramifications, both fiscally and socially, than a forced recall by the U.S. Food and Drug Administration (FDA). Whether your recall is Class I, Class II, or Class III, you need to understand the process completely and know what proactive steps you can take.

Angela Bazigos has more than 40 years of experience in the medical industry: She’s worked on quality assurance, regulatory compliance, project management, and clinical lab science. Join her for this in-depth virtual boot camp to examine FDA’s medical device recall policy. Learn how to determine if you are affected, what your firm’s responsibilities and action points are, what exceptions there are to the FDA process, and what sort of enforcement action you can expect.

After attending this event, you will know how to create a communication and recall strategy, what you need to follow up on, how to obtain recall status reports, and what factors to consider when recalling a device. You will also fully understand FDA’s enforcement policy, expectations, recall classification, and recall termination status. Learn all the ins and outs of this process before the FDA comes calling!

Session Highlights

Here is a taste of what you will uncover:

  • What a recall is and who can initiate one
  • How to determine if you have a medical device recall
  • How to report correction and removal
  • Your responsibilities during a recall
  • How to avoid consequences or risks to health
  • Safety alerts
  • Solid recall strategies, communication plans, and follow-up responsibilities
  • Things to consider when recalling a medical device
  • FDA’s enforcement policy, expectations, and role
  • Recall classifications
  • Recall terminations
Session Details
Session 1: Determining and Initiating the Need for a Recall

Length: 60 Minutes

Session 2: Firm’s Responsibilities and Action Points

Length: 60 Minutes

Session 3: FDA’s Expectations and Enforcement Policy

Length: 60 Minutes

Who Will Benefit?
  • Regulatory affairs officers
  • Clinical trial physicians and doctors
  • Quality assurance officers
  • Clinical investigators
  • Biostatisticians
  • Institutional review board members
  • Data monitors
  • Members of medical device companies, medical device CROs for clinical studies, clinical investigators, and institutional review boards
About Our Speaker

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / client... Read More

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