Description

Unique Device Identification (UDI) is an XML schema developed to support medical device documentation that is formatted to the FDA’s new Global Unique Device Identifier Database (GUDID). This workshop will cover the commonly used element, attribute and entity constructs that are defined in the schema. More importantly, recommendations concerning how best to implement UDI solutions will be given. This UDI Compliance Training Course will introduce the new FDA UDI regulation and compliance dates, as well as the requirements for submission to GUDID. Dakota Systems customizes the training to fit the needs of each team. Training will enable our clients to:

• Understand the compliance requirements for UDI.

• Interact and engage in hands-on activity; the course will be delivered on-site to a group of 4 to 8 attendees.

• Choose the best labelling standard.

• Have a solid understanding of the UDI standard and how it can be utilized most effectively.

• Outline a solution that validates and submits UDI data to GUDID.

Audience

The primary audience for this course is developers, architects or system analysts that intend to utilize a UDI schema within their organizations. A solid understanding of XML concepts and experience creating documents with structured markup are prerequisites for this class.