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.
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
For Registration-
http://www.onlinecompliancepanel.com/ecommerce/webinar/~product_id=500934?expDate=August27_2015_MedicalequipmentSales=Channel=printweek
The implementation or “compliance” timelines for the regulation
Note : Use coupon code 1371 and get 10% off on Regsitration
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