The document summarizes an upcoming webinar about Unique Device Identification (UDI) rules and requirements for medical device industries, hospitals, and providers. The webinar will cover current and upcoming FDA UDI policies, including timelines and guidance documents. It will explain UDI codes and standards, requirements for different industry roles, and how organizations should prepare to comply with increasing regulatory complexity around medical device identification and post-market surveillance. The webinar aims to help participants from various medical device and healthcare roles understand and conform to evolving UDI regulations.

1. Unique Device Identification (UDI): Upcoming FDA rules, requirements and timelines for
industry
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.
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.

2. 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
For more details please visit our site:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703039