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.
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.
We will also explore relevant UDI and standards in US and we will present the proposed regulations and cases in the field. We will analyze a recent report that FDA published on strengthening the medical device post-market surveillance and UDI plans that will affect the industry in the coming years. Finally we will expand on current similar UDI initiatives and effort at EU and globally and the role of Global Harmonization Task Force (International Medical Device Regulators Forum currently).
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.
We will also explore relevant UDI and standards in US and we will present the proposed regulations and cases in the field. We will analyze a recent report that FDA published on strengthening the medical device post-market surveillance and UDI plans that will affect the industry in the coming years. Finally we will expand on current similar UDI initiatives and effort at EU and globally and the role of Global Harmonization Task Force (International Medical Device Regulators Forum currently).
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)
- Post-Market Surveillance & Compliance with UDI
- Lawmakers doubt the release of UDI rule by deadline (2013)
- UDI efforts and recommendations in EU and globally
- Global Harmonization Task Force & International Medical Device Regulators Forum
- Future Of Medical Devices pre- and post-market lifecycle.
Who Will Benefit:
- Manufacturers of Medical Devices (Industry)
- User Facilities of Medical Devices(Hospitals, Clinics)
- Importers, Customs & Border professionals
- Medical Device distributors
- Medical Compliance Officers
- Health Information Managers
- Legal Counsel, Regulatory affairs
- Data and Device Standards experts
- Health care distributors
- Group purchasing organizations
- Hospitals and health care providers
- Health care industry professionals
- Healthcare & Devices CIO/CFO/CTO
- Audit/Inspection coordinators, internal auditors
- QA/QC managers, executives and personnel
- Health IT/IS managers and personnel
- Entrepreneurs (Devices, Surveillance, Informatics)
- Consultants and Strategists
Course Provider
Kosta Makrodimitris,
