IMPACT OF UDI ON GLOBAL TRADE, HOW TO CREATE A GLO 2016 - Update on Global UDI Initiatives for Medical Devices-By Compliance Global Inc

Website https://www.complianceglobal.us/product/700608/LenaCordie/global-unique-device-identification-initia | Edit Freely

Category Healthcare,Medical Device

Deadline: November 17, 2016 | Date: November 17, 2016

Venue/Country: online, U.S.A

Updated: 2016-10-19 20:18:54 (GMT+9)

Call For Papers - CFP

This webinar will provide updates on the progress of unique device identification regulations around the world, including the status of the FDA’s implementation, requirements for UDI in the new EU MDR, the NHS e-procurement and PEPPOL programs in the UK, and the development of initiatives in other countries including Australia, Canada, Japan and Asia.

Unique identification and barcoding are neither new technologies nor innovative concepts. But incorporation of UDI into the medical device industry has been long discussed and planned and slow to be implemented.

What has taken this major industry so long to adopt UDI and barcoding? Why are both manufacturers and hospital systems reticent about implementing it?

Why Should You Attend:

Knowledge, planning, preparation. These are the foundation principles for any successful and sustainable project, especially one as global and multi-faceted as Unique Device Identification. It is never too soon to begin increasing your awareness of the various programs being established and your knowledge of the requirements and timelines to help you begin planning and preparing for what is inevitably going to be a challenging, resource-heavy, and time-consuming process.

Medical device manufacturers of all sizes, locations, product class, and expertise are in the same precarious position of uncertainty and waiting. By strengthening your UDI intelligence now, you will be better positioned to lead your organization in this global initiative.

Areas Covered in this Webinar:

Intent of Unique Device Identification regulations

Why are countries creating regulation for UDI?

What is the purpose of the regulation?

Current efforts & hurdles to harmonization

Key differences in proposed regulations

Standards

Label requirements

Data reporting

Comparison of IMDRF/ US FDA/ EU

Timelines – known & anticipated

Impact of UDI on global trade & commerce, product cost, and patient safety

Enforcement actions

Learning Objectives:

Be aware of what UDI information to look for and where to find it

Be able to outline a general UDI strategy by identifying and prioritizing the “critical to business” regulations you need to address first

Who Will Benefit :

Regulatory Affairs Professionals,

Quality Assurance Professionals

Labeling Specialists,

Master Data Managers,

Supply Chain Professionals

For more information, please visit : https://www.complianceglobal.us/product/700608/LenaCordie/global-unique-device-identification-initiatives-for-medical-devices/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile :

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.