Webinar On Establishing an FDA-Compliant UDI System

Description :

This seminar is intended to help you effectively implement a unique device identification (UDI) system based on the final rules issued and published in federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.

In this 60-min presentation, the speaker will guide you through the details of how to implement the UDI system requirements in a CAC-SI manner. You will have opportunities to bring great value and benefits to your firm’s implementation of a UDI system in an efficient and effective manner.

Areas Covered in the Session :

Applicable Statute(S), Regulations and Enforcement Authority

Definitions

UDI Development History

UDI Final Rules: Technical Requirements and Changes Made

When to Use a UDI and When to Discontinue Its Use, and When to Use a New UDI

UDI System Requirements including Technical Standards

Requirements for a Unique Device Identifier

FDA Accreditation Process for an Issuing Agency including Suspension and Revocation

UDI Rules: Applicability, Exceptions and Alternatives

Devices at a Retail Store, Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals

Devices Labeled Prior to Compliance Dates

Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)

Class I Devices: cGMPs Exempted

When to Request Exceptions and Modifications

Which Devices Not Required to Have a Production Identifier

Direct Marking Requirements and Revised Changes

Requirements for Stand-Alone Software

Compliance Dates for the Applicable Requirements Over 7 Years

Device Identifier Formats including Dates

Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)

Impact of the Final Rules to Many Business Areas/Processes

Changes in Device Design, Documentation and Manufacturing Processes

Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast

Conclusion

Who Will Benefit:

R&D Scientists, Managers, Directors, and VPs

Regulatory Affairs and Compliance Professionals

Clinical Affairs Professionals

Quality Professionals

Consultants

Legal and Compliance Officers

Marketing Professionals

Senior Management

Anyone Interested in the Subject