FDA's Emerging Signals Guidance: Reporting Medical Device Safety Warnings

Duration: 60 Minutes
On 31 December 2015, the FDA published draft guidance for Industry and FDA Administration. The FDA accepted comments from industry through 29 March 2016. Based on the comments, it is likely that the guidance will change. However, it is clear that the FDA is actively taking steps in asserting its mandate to protect the public health. In this webinar we will discuss how to transform your quality management system from compliance-based to quality-based.
FDA’s Emerging Signals Guidance
Instructor: Susanne Manz
Product ID: 501576
Objectives of the Presentation
  • Understand the proposed guidance on "Emerging Signals"
  • Understand other areas of change such as eMDR and UDI that allow faster and more precise information
  • Discuss the implications of these changes
  • Understand how to change your Quality Management System from Reactive to Predictive
  • Explore ways to prepare for FDA changes
Why Should you Attend
The FDA is asserting its mandate to protect the public health with a proposal for notifying the public about "emerging signals". This proposal, along with other changes, will allow the FDA to more quickly identify, analyze, and notify the public of potential issues. In addition to recall notices, safety communications, and press releases, "We believe there also is a need to notify the public about emerging signals that the Agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations," FDA states in draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').

Areas Covered
This 60-minute webinar will focus on:
  • Guidance on Emerging Signals
  • Unique Device Identifier
  • Electronic MDR reporting
  • Case for Quality
  • Moving from Reactive to Predictive Quality Management
Who can Benefit
  • Quality Systems Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Quality/Compliance managers or directors for Medical Device companies
  • General Managers wanting to strategize and prepare for future changes
Topic Background
FDA published draft guidance for Industry and FDA Administration on 31 December 2015. The FDA accepted comments from industry through 29 March 2016. Based on the comments, it is likely that the guidance may change. However, it is clear that the FDA is actively taking steps in asserting its mandate to protect the public health. Along with other changes such as UDI (Unique Device Identifiers) and eMDR (Electronic Medical Device Reporting), the FDA is creating a system to quickly obtain, analyze, and respond to quality problems with medical devices.
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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