UDI Deadline for Implantable and Life Sustaining Devices 2015

Time's Up! Mandatory Unique Device Identification for Implantable and Life Sustaining Devices Starts September Instructor: Dawn Haake Product ID: 500934 Description As the compliance deadline is nearing for the FDA's UDI (Unique Device Identification) for Implantable and Life Sustaining Devices, it is important that companies understand which part of the regulation apply to their specific products, what will be required to meet the regulation, and what timelines they must follow to stay in pace with the FDA's tiered compliance approach. By understanding what aspects of device labeling and listing are impacted, companies can ensure they remain in step as each phase comes into effect. Areas Covered The regulations impacted by UDI, and how they have changed UDI definitions UDI partners: Accredited agencies, Dun and Bradstreet and GMDN UDI compliance dates The GUDID account Setting up and maintaining GUDID records The exemption process Why Should you Attend Attending this course will help you to understand who is impacted by the UDI regulation, what must be done to comply, and when these activities must be completed to remain compliant with the new requirements. Objectives of the Presentation What the UDI regulation entails, from labeling requirements to product listing What third parties you will need to work with to meet requirements What steps will be required to establish your GUDID account What information will be needed to maintain GUDID records What options are available to populate the GUDID with your product records The implementation or “compliance” timelines for the regulation Who can Benefit Individuals within the Medical Device Industry who are responsible for Product and Labeling Development Regulatory Affairs and Regulatory Compliance Quality Assurance Supplier Management Inventory Management Logistics Distribution and Information Technologies will need to be familiar with the requirements of UDI For Registration- http://www.onlinecompliancepanel.com/ecom