About the Conference

Recalls and other field actions are unavoidable in the medical device industry. How manufacturers evaluate risks and manage recalls makes a significant difference in public safety and a company’s reputation and bottom line.

Conducting a health hazard evaluation (HHE) and the initiation, execution, and termination of a recall pose countless challenges. When is an HHE indicated?  How does FDA’s HHE process differ from those used by industry? How does one estimate the probability or degree of risk – too often on the basis of incomplete information? What other factors should be considered?  Who ought to be involved in evaluating the information and making the ultimate recall decision, then in overseeing implementation of the process? What are best practices for external communications, and when does one terminate a recall?

This two-day conference offers a unique opportunity to hear and interact with key FDA and industry experts on the thought processes, procedures, and practical issues involved in medical device recalls.

Topics will include:

  • Recall and field action regulations, definitions, and expectations
  • FDA guidances, observations, and new initiatives related to recalls
  • When and how to conduct an HHE
  • Assembling and coordinating a recall team
  • Formulating a recall strategy
  • Recall execution
  • Communicating with FDA during HHEs and recalls
  • Recall communications to health care providers and other stakeholders
  • Investigating, documenting, and reporting non-recall field actions
  • Effectiveness checks
  • Terminating a recall

 Who should attend:

  • Regulatory and quality professionals
  • Executive management
  • Clinical and medical affairs officers
  • Product surveillance and safety personnel
  • Risk management professionals
  • Compliance officers
  • Corporate and regulatory counsel


CEU Information

Attendees can earn CEUs. 1 hour of the conference = 1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MTI's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

  • When

  • Thursday, October 26, 2017 - Friday, October 27, 2017
    9:00 AM - 3:30 PM

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