Unique Device Identification (UDI) Implementation Workshop

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The one-day virtual seminar provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter.

The virtual seminar gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID

The seminar helps you identify the requirements for the UDI elements:

Procedure changes
Label UDI
Package UDI
Direct marking UDI
Date format
Entry into GUDID

The seminar helps you implement the changes, update your procedures, and determine when you need to revalidate databases.

Who will Benefit:

Regulatory Managers
Design Engineers
Labeling Specialists
Project Managers
Quality Managers
Quality Engineers
Executive management
R&D staff
Strategic planning staff

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

The real-time and live presentation as in in-person events
Private chat for company-specific conversation – the same as you would get in an in-person seminar
Opportunities to connect with your peers to share knowledge at a different time and have group discussions
Live workshop activities
Live Q&A during the event and offline Q&A assistance after the event
As usual more content, activities and case studies and now adding homework for a comprehensive understanding
Certification

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Topic Background:

All medical devices marketed in the US, with limited exceptions, must have unique device identification. The first phase is the revised regulations with an effective date of Dec. 23, 2013.

The subsequent phases depend on device attributes such as regulatory class, intended use (life sustaining or life supporting), reusable & reprocessed, etc. FDA-CDRH published a simple table, by compliance date. However, device manufacturers need a more refined analysis to classify their products and determine the compliance dates.

For each compliance date, depending on the device characteristics, the manufacturer puts the UDI on the label, changes the label’s date format, includes the UDI on packaging configurations, and enters information into the FDA-CDRH database called the GUDID. In some case, the manufacturer puts the UDI on the device itself.

By September 24, 2016, all manufacturers of Class 2 devices must implement UDI (label, package, and GUDID). You need to understand the regulation and develop your plans now or you won’t be ready. There are a lot of details in the implementation and you will need time to handle all of them.

You need to plan your implementation. You have only two choices.

You could assign somebody as the subject matter expert. This means reading and understanding the 160 page final rule as well as the ever changing guidance documents
You could send your implementation team to this workshop designed to clarify the requirements and provide hand-on practice in the implementation

Day 01(12:00 PM to 6:00 PM EDT)

12:00 PM – 1:15 PM - Overview of the UDI Rule
- Distinguishing among Identification, Tracking, and Tracing
- The elements of the system: UDI and GUDID
- Determining applicability
- Determining compliance dates
- UDI locations: device, label, and package
- The GUDID and its data elements
- The required organizational structure
- Loading the data into GUDID
- Change control (when you need a new DI)
- Exercise – Participants review cases to determine if a change requires a new device identifier
1:15 PM – 1:30 PM - Break
1:30 PM – 3:00 PM - Device, Label, & Package UDI
- UDI = DI + PIs
- Compliance Dates
- Direct Marking
- Device Label
- Package Configurations
- Accredited Issuing Agencies
- UDI Specification by Issuing Agency
- Exercise – Participants review cases to determine the compliance date
- Exercise – Participants apply the packaging configuration rules
3:00 PM – 4:30 PM - Populating the GUDID
4:30 PM – 6:00 PM - Updating the QMS
- Quality System Regulation
- Medical Device Reports
- Corrections and Removals
- Record Retention
- FDA Inspections
- Related Issues
  - 510(k)
  - eMDR

Lena Cordie Bancroft
President, Qualitas Professional Services, LLC

Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.

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Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

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Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions for In-person Seminars:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Cancellations and Substitutions for Virtual Seminars & Webinars:

Written cancellations through fax or email (from the person who has registered for the training) received at least 10 calendar days prior to the start date of the event will receive a refund — less a 30% administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event. On request by email or fax (before the training) a credit for the amount paid minus administration fees (30%) will be transferred to any future ComplianceOnline event and a credit note will be issued. Substitutions may be made at any time. No-shows will be charged the full amount. Some topics and speakers may be subject to change without notice.

Offers:

Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.