FDA's Emerging Signals Guidance: Reporting Medical Device Safety Warnings
Duration : 60 Minutes
Susanne Manz,
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 an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineerin Read more
On 31 December 2015, the FDA published draft guidance for Industry and FDA Administration.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.
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analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations," FDA states in draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').
Course Objective:
• 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
Course Outline:
• Guidance on Emerging Signals
• Unique Device Identifier
• Electronic MDR reporting
• Case for Quality
• Moving from Reactive to Predictive Quality Management
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Point
Who Will 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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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