Time's Up! Mandatory Unique Device Identification for Implantable and Life Sustaining Devices Starts September

Duration: 90 Minutes
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.
UDI Deadline
Instructor: Dawn Haake
Product ID: 500934

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
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dawn Haake is the Senior Director of Global Quality Assurance for a leading developer of spinal orthopedic surgical solutions in Southern California. With over 25 years of experience working within the quality field in organizations such as Infrasonics, Nellcor Puritan Bennett, Mallinckrodt and Covidien (formerly Tyco Healthcare), Ms. Haake has had extensive input into the creation, maintenance and regulatory presentation of Quality Management Systems designed to address a broad range of device applications and classifications, from complex Class II and III microprocessor controlled life support systems to high volume sterile disposables such as surgical kits and suture devices.

Ms. Haake has developed worldwide systems for the management of Corrective and Preventive Action activities, Quality Improvement Teams, Internal Audit Systems, Operational Excellence Programs, Online Learning Management Systems, Clinical Study Safety and Clinical Events Committee Management. Ms. Haake holds a BA from the University of Massachusetts, Amherst with a concentration in Medical Quality Management Systems.
View More