Objectives of the Presentation
Why Should you Attend
- 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
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analyzed, validated, or confirmed, and for which the Agency does not yet have specific recommendations," FDA states in draft guidance entitled Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').
This 60-minute webinar will focus on:
Who can Benefit
- Guidance on Emerging Signals
- Unique Device Identifier
- Electronic MDR reporting
- Case for Quality
- Moving from Reactive to Predictive Quality Management
- 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
FDA published draft guidance for Industry and FDA Administration on 31 December 2015.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.