Event:
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Unique Device Identification (UDI): Upcoming FDA rules,
requirements and timelines for industry
- Hosted By:
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ComplianceOnline
- Start:
- Thursday - Aug 01, 2013 10:00 AM
- End Time:
- Thursday - Aug 01, 2013 11:30 AM
- Location:
- Online
- This webinar will help you understand and comply to the Unique Device Identification (UDI) policies, both current and the upcoming FDA requirements for importers, manufacturers and hospitals.
Why Should You Attend:
Medical device industries (manufacturers), hospitals and providers should plan proactively to prepare systems and processes in order to meet the upcoming UDI requirements and rules. It is critical to get informed on all these guidances for different stakeholders in order to understand better the increasing complexity of the device regulatory process (premarket, postmarket).
This webinar will provide the current and expected policies for Unique Device Identification (UDI) in US regulated by FDA. We will explain the current guidances (Food and Drug Administration Amendments Act of 2007, proposed rules and amendments in 2012), update on upcoming UDI rules and discuss what industry and hospitals should know to conform to UDI rules. This course will explain the requirements for all these roles in industry that need conformance to the regulations and the standard process. The FDA (ISO) codes and standards for UDI data and processes will be described in details at this webinar.
Areas Covered in the Webinar:
- Overview and timeline of UDI
- Proposed UDI regulation(FDA, 2012)
- Amendment to the UDI Proposed Rule(2012)
- UDI codes and standards
- Proposed dates for UDI regulations in US
- Benefits of UDI (supply chain, healthcare, industry, public health)
- Website:
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Visit the website for detail info