If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
UDI: What & How within the overall Medical Device value chainnancykathlen
Free Webinar on Unique Device Identification (UDI): What & How within overall Medical Device Value Chain June 18th 2015. This webinar provides insights into various aspects of UDI, discuss the operational aspects of implementing and integrating UDI within the overall Medical Device value chain.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
This presentation will provide a comprehensive knowledge on current UDI labeling standards and how medical device companies can implement the best practices to assure compliance.
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
Unique Device Identification UDI Requirements and Timelines Joe Hage
http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
12 Steps for Medical Device UDI Submissions to the FDA GUDIDJoe Hage
UDI regulations kick in for Implantables and Class II devices in 2015.
Reed Tech subject matter expert Gary Saner is my go-to on this subject. He covered:
• Requirements of a GUDID submission system
• Process steps in selecting/launching a GUDID system and making submissions
• Data Fields – including those that are problematic
• Data Cleaning, Harmonization, and Validation tips
• Update on FDA’s changing GUDID guidance, e.g., convenience kits and implants
• Notes in setting up a FDA GUDID account
RELEVANT FOR:
• UDI Team Leaders/Members
• Regulatory Directors/Managers/Staff
• Manufacturing, Operations, and Supply Chain Logistics Personnel
• UDI IT Support Personnel
• Compliance Officers
• Distributors with UDI Submission Responsibilities
Video at http://medgroup.biz/UDI-in-2015
Unique Device Identification UDI Requirements and Timelines Joe Hage
http://MedicalDevicesGroup.net Reed Technology, in collaboration with the Medical Devices Group, present information regarding the FDA's Unique Device Identifier (UDI) and discuss strategies to implement your UDI submissions solution.
Global unique device identification database (gudid) and udiJoe Hage
Medical device companies are affected by the Unique Device Identification ruling from FDA. UDI experts Reed Tech help members of the Medical Devices Group understand the complexities.
You can find the audio replay and transcript at http://medgroup.biz/unique-device-identification
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Unique Device Identification: Manufacturer, Hospital and Global ImplicationsApril Bright
Unique device identification (UDI) is gaining global adoption. Now is the time for companies to take a step back and ask: Is my UDI framework scaleable? UDI experts answered questions on the U.S. regulation and provided perspective on ways that device manufacturers can implement a working system—including data management—that can scale with product development and UDI compliance needs. Attendees gained an understanding of new global regulations and practical, implementable advice for compliance.
FREYR UDI VISION SERIES SESSION 1 - UDI READINESSFreyr Solutions
Very few device manufacturers have experienced the impact and challenges faced during UDI compliance. A very crucial aspect being aware and assessing the level of UDI readiness, implementation of appropriate standards, feasible technologies and ultimately achieving UDI compliance is a major task.
As per FDAs UDI final ruling, GUDID will accept only DI information and it is the responsibility of the medical device manufacturer to maintain the PI information for any future regulatory and quality audits
This short presentation is giving a brief introduction of the general status of china medial device industry, as well as an explanation about the CFDA and the medical registration process in china
Implementing a Global Unique Device Identification (UDI) Solution: Regional U...Greenlight Guru
UDI data requirement experts Gary Saner and John Lorenc of Reed Tech will discuss best practices for UDI preparations and the future potential impacts to medical device manufacturers as global health authorities publish mandates.
This session will give suggested best practices concerning EU EUDAMED preparation, what we have learned via testing and a Q&A session. Bring your specific questions concerning medical device registration scenarios, data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer your questions concerning EUDAMED and other health authority timelines.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
On September 24, 2013, the U.S. Food and Drug Administration announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI. Explore on how Freyr can help medical device companies achieve UDI compliance.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
As UDI deadlines roll out, OEMs are left with many questions on implementation and compliance, including:
How does FDA recommend we direct mark screws and small implants?
How should we proceed as we await the guidance on the Convenience Kit exemption?
What are best practices for entering submissions to GUDID?
How is FDA enforcing UDI?
FDA officials will speak on UDI adoption and UDI data quality. Bring your questions. Ample time will be saved for Q&A.
Through practical case studies and industry specific analysis sessions, Medical Device UDIs & Traceability Forum Europe 2015 is geared around strengthening your regulatory infrastructure, maintaining productivity and ensuring ROI from your UDI projects.
View the full agenda here: bit.ly/MedicalDeviceUDI2015Agenda
Alternatively, email enquire@iqpc.co.uk or call +44 (0)207 036 1300 for a copy.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
The Medical Device Manufacturer's Quick Reference Guide to UDIBlytheco
Medical device manufacturing companies and the healthcare industry in general have been struggling with medical device tracking and recalls for a number of years. Over the last decade, medical device recalls have doubled.
As a result, the FDA has introduced requirements for Unique Device Identification (UDI). Are you up to speed on the requirements and deadlines? See our infographic for a quick reference tool.
The Medical Device Manufacturer's Quick Reference Guide to UDIKathy McCoy, MBA
Medical device manufacturing companies and the healthcare industry in general have been struggling with medical device tracking and recalls for a number of years. Over the last decade, medical device recalls have doubled.
As a result, the FDA has introduced requirements for Unique Device Identification (UDI). Are you up to speed on the requirements and deadlines? See our infographic for a quick reference tool.
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
EU regulatory frameworks - Legal challenges and opportunities for digital hea...DayOne
Presentation by Karin Schulze, Head of Medical Devices at SFL at the DayOne Expert Event Legal challenges and opportunities for digital health innovation
Regulation
Regarding the new MDR, the big question that arises is not only whether a piece of software falls under the definition of a medical device, but also who decides whether it does. At least in this regard the new regulation is clear: it is the regulator. Which means, according to Karin Shulze from SFL, that If a company offers an app which they do not consider a medical device themselves, but the regulator does, the distribution of this app will be stopped.
The Unique Device Identification System for Class I and Unclassified DevicesEMMAIntl
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have time to comply with the UDI system...
PTC Successfully Submits Test Data to the FDA’s Global Unique Device Identifi...PTC
PTC (Nasdaq: PTC) announces it has successfully submitted UDI data to the preproduction version of the US Food and Drug Administration’s Global Unique Device Identifier Database (GUDID) through the Electronic Submission Gateway (ESG) in the required HL7 SPL format. The FDA’s UDI rule aims to dramatically reduce the instances of patient injury and death that result from the misidentification of medical devices.
Wearable technologies and remote patient remote monitoring systemGiulio Coraggio
This presentation focuses on issues related to wearable technologies in the healthcare sector whose main expression has been given so far by the so called remote patient monitoring systems
Inventory and Production Tracking to the Clouddavid_h
How is cloud computing changing how we track and control inventory and production.
This presentation by my friend Peter Green of BellHawk discuss this.
Barcodes in Action - Barcode GeekFest Slidesdavid_h
My presentation from the Path to Labeling success Event.
Covers barcode standards and symbologies, compliance, 2D barcodes and using barcodes for authenticity.
From Winco ID's Barcodes & Baseball event - David Holliday's presentation on using barcodes to give items a digital voice to enable them to talk to us.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
India Orthopedic Devices Market: Unlocking Growth Secrets, Trends and Develop...Kumar Satyam
According to TechSci Research report, “India Orthopedic Devices Market -Industry Size, Share, Trends, Competition Forecast & Opportunities, 2030”, the India Orthopedic Devices Market stood at USD 1,280.54 Million in 2024 and is anticipated to grow with a CAGR of 7.84% in the forecast period, 2026-2030F. The India Orthopedic Devices Market is being driven by several factors. The most prominent ones include an increase in the elderly population, who are more prone to orthopedic conditions such as osteoporosis and arthritis. Moreover, the rise in sports injuries and road accidents are also contributing to the demand for orthopedic devices. Advances in technology and the introduction of innovative implants and prosthetics have further propelled the market growth. Additionally, government initiatives aimed at improving healthcare infrastructure and the increasing prevalence of lifestyle diseases have led to an upward trend in orthopedic surgeries, thereby fueling the market demand for these devices.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
Falcon stands out as a top-tier P2P Invoice Discounting platform in India, bridging esteemed blue-chip companies and eager investors. Our goal is to transform the investment landscape in India by establishing a comprehensive destination for borrowers and investors with diverse profiles and needs, all while minimizing risk. What sets Falcon apart is the elimination of intermediaries such as commercial banks and depository institutions, allowing investors to enjoy higher yields.
What are the main advantages of using HR recruiter services.pdfHumanResourceDimensi1
HR recruiter services offer top talents to companies according to their specific needs. They handle all recruitment tasks from job posting to onboarding and help companies concentrate on their business growth. With their expertise and years of experience, they streamline the hiring process and save time and resources for the company.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Accpac to QuickBooks Conversion Navigating the Transition with Online Account...PaulBryant58
This article provides a comprehensive guide on how to
effectively manage the convert Accpac to QuickBooks , with a particular focus on utilizing online accounting services to streamline the process.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
2. Seminar Agenda
Welcome and Introductions
UDI – what is it all about?
GS1 or HIBCC?
Flexcon’s View on UDI
GUDID Database
Resources for moving forward
Live demos and networking
7. A Medical Device is…
"an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part, or accessory
which is:
recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and which is not
dependent upon being metabolized for the achievement of any of its primary
intended purposes."
8. What’s UDI All About?
“The Food and Drug Administration
(FDA) is issuing a final rule to
establish a system to adequately
identify devices through distribution
and use…”
9. What’s UDI All About?
”This rule requires the label of
medical devices to include a
unique device identifier
(UDI)…”
“The labeler must submit product
information concerning devices to FDA's
Global Unique Device Identification
Database (GUDID)…”
10. What’s UDI All About?
OK, so we have to identify things with some UDI thingy &
send some info to a database?
Sounds easy enough!
Let’s look in a little more detail…
11. Know your DUNs No and
D&B Address
Ensure you have your
company prefix from your
chosen Issuing Agency
Get all the data together for
labeling and for the GUDID
Database
Have your GMDN account
and get the nomenclature
for your products
Develop labels and package
marking for each layer of
packaging
QA Plan to validate labeling
and barcodes
Test – Validate – Test some more!
Sign up for GUDID access.
Determine how you’ll
upload data
13. What’s UDI All About?
UDI Acronyms
Meaning
DUNS
D&B Number – needed for GUDID
UDI
Unique Device Identification
GLN
Global Location Number GS1
GTIN
Global Trade Item Number GS1
GMDN
Global Medical Device Nomenclature
GUDID
Global UDI Database
DI
Device Identifier
PI
Production Identifier
AIDC
Automatic Identification and Data Capture
GS1
The GS1 Standards Organization
HIBCC
Health Industry Business Communications Council
ICCBBA
Bonus points if you know this one!
14. What’s UDI All About?
What is a UDI?
The UDI is defined as consisting of 2 parts:
The company is called
“The Labeler “ in the Rule
Device Identifier – DI
This identifies the company and the model of the device
Production Identifier – PI
Production data such as Lot number, Expiration Date, Serial Number
The information must be provided in plain text and in AIDC form.
The Rule is flexible on what AIDC technology is used!
15. What’s UDI All About?
What is Device Identifier (DI)?
DI = the static part of the UDI.
Consists of:
Company Prefix + Item Number
These will depend on the Standards being used
?
16. What’s UDI All About?
What is Production Identifier (PI)?
PI = the dynamic part of the UDI.
Consists of one or more of:
Lot number
Serial number
Expiration date
Manufacturing date
22. What’s UDI All About?
Barcode Standards
Expiration Date
Data Identifier
Data Identifier
Supplier LIC &
Part Number
Data Identifier
Lot Number
Issuing Agency Code (RH)
Data Identifier
Data Identifier
Packaging Level (0 = unit of use)
Manufacture Date
23. What’s UDI All About?
Barcode Standards
Datamatrix Code
QR Code
Aztec Code
Micro PDF Code
24. What’s UDI All About?
Barcode Standards
GS1
HIBCC
Making inroads in medical
Well established standard
GTIN is numeric only
Can use existing cat. #s
Huge international presence
Mainly in North America
Annual fee
One time fee
Standard in many logistics chains
?
If I were a betting man…
25. What’s UDI All About?
RFID Standards
FDA, GS1 & HIBCC all allow for RFID
Note that HIBCC suggests 13.56Mhz
26. What’s UDI All About?
ICCBBA ISBT 128
International Council for Commonality in Blood Banking Automation
28. What is a medical device?
The Product Code assigned to a device is based upon the medical device
product classification designated under 21 CFR Parts 862-892. Three
classes exist today.
A very wide range of medical products such
as:
Traditional hospital based devices (beds, ventilator, monitors, infusion pumps)
Implants (teeth, hips, etc…)
Patient/home use devices (glucometers)
Disposables, accessories (glucose test strips, catheters)
In vitro diagnostic devices (IVDs) – both clinical lab and Point of Care (POC).
Those used in alternative sites – e.g., homecare, dental
Health Information Technology (HIT)
Convenience kits, Combination products
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29. Today’s view without UDI
Product tracking efforts and recall difficult
Current systems allow product re-identification by every stakeholder in the supply
chain today
Healthcare Supply Chain will be able to use the same Unique Device Identifier!
Manufacturer
Product # 305905
Distributor
Product
# MT305905
Hospital or Healthcare Provider
Product # M-5905
Courtesy of Jackie Rae Elkin of Medtronic, Inc.
Global Process Owner - Standard Product Identification
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30. Two FDA systems are UDI and SNI
UDI: Unique Device Identification
FINAL Rule!!!
Medical devices
Patient care, diagnostic or treatment devices
Moving forward
SNI: Standardized Numeric Identification
Prescription drugs
Pharmaceuticals
Biologics
Vaccines
Stalled due to recent politics
Guidance
31. Timelines of Final Rule
Implementation (compliance) timeframes are
generally the same from Proposed Rule:
Year 1: class III and devices licensed under PHS Act
Year 2: class II/I implants and lifesupporting/sustaining
Year 3: rest of class II
Year 5: class I
Note For Direct Marking!
Compliance dates are extended by 2 years
Except for FDASIA (year 2) devices – still at year 2.
The start date is 9/24/13
32. What Changed from Proposed
Rule High Level?
DIFFERENCES from the PROPOSED RULE:
Combination Products and Kits topics
ironed out
Packaged Single Use Devices (SUDs)
exempt with a common sense
approach (the band-aid in the box
issue)
Direct Marking for direct patient reuse / sterilization equipment
Direct part marking for organic
implants not mandated is another
common sense logical concession that
was well received
•
•
•
•
•
•
New Version or Model revised
NDC/NHRIC Numbers
UPC Exception for Class 1 more
logical approach
Definitions are clearer in the rule
GUDID database has more quality
attributes
Issuing Agencies are now only
private entities and not nonprofit, public, or government.
33. What does a possible UDI look like?
E.g., The new GTIN that is purchased and linked to the Enterprises’
production information enables the benefits of the UDI initiative
34. Goals of the UDI Initiative
Reduction of medical errors
Identify compatibility issues
Improve medical device reports (MDRs)
Identify and reduce product counterfeiting
More efficient purchasing, reimbursement, and supply chain
management, thus lowering costs
Enhance medical device asset utilization
Enhance in post-market device surveillance
Support recall of medical devices
Enable chain of custody tracking
Capture device information in Electronic Health Record
35. UDI Transactions are Three Parts
Reformat your data using an approved
registration authority
Encode the data in AIDC format
Print your label
Label your product
Register your UDI in the FDA data base
Ship the Product
36. FDA’s UDI Database
Database will be an open, public
database, access shall be free of charge
UDI Device Identifier will be primary key in
the database with associated product
data elements defined
Manufacturers will be responsible for
submitting and maintaining their own
data in the database
All data submissions will need to be in the
HL7 Structured Product Labeling (SPL)
format.
Guidance Released 9/24/13
37. History of the UDI Regulation
1999 IOM Report – To Err is Human
2004 FDA Pharmaceutical Barcode Rule
2005 and 2006 FDA/FDLI Meeting on UDI with IOM Famous Quote
2006 Public Meeting and Docket FDA-2006N-0292
2007 FDA Amendments Act of 2007 (Congress Passes Law)
2007-2009 – UDI Database Pilots
2008 GHTF Ad-Hoc Working Group on UDI
2009 UDI Workshop and Docket FDA-2008-N-0661
2011 GHTF UDI Guidance published
2012 July 10th - UDI Proposed Regulation Publishes
2012 FDASIA provisions added and Congressional Law to Publish
2012 November 7th – comment period closes for Proposed Rule
2012 November 19th – FDASIA amendment (Dec 19) - “Med Tax”
2013 June– UDI Final Rule sent to OMB
2013 UDI Conference in Baltimore
YOU ARE HERE on 9/24/13
2013 Final Rule Published
38. The Status as of 9/24/2013
Published Final Rule with comment period
http://www.fda.gov/MedicalDevices/Devi
ceRegulationandGuidance/UniqueDeviceI
dentification/
Courtesy FLEXcon 2013
39. FLEXcon® MedFLEX™
A series of polyester products UL-recognized
2 mil silver matte, clear and white
Topcoat is more universally printable
High performance acrylic adhesives
Printable via UV, Emulsion and UV Ink jet
Liner is suitable for optical scanning
IEC compliance pending
Overlaminates
Choice of 1 mil clear and clear matte polyester films
47. Printing Your UDIs
TTO – print on flexible packaging
Zebra printers for durable labels
Laser marking solutions
for direct part marking
IDT Labelers – cases and pallets
50. Know your DUNs No and
D&B Address
Ensure you have your
company prefix from your
chosen Issuing Agency
Get all the data together for
labeling and for the GUDID
Database
Have your GMDN account
and get the nomenclature
for your products
Develop labels and package
marking for each layer of
packaging
QA Plan to validate labeling
and barcodes
Test – Validate – Test some more!
Sign up for GUDID access.
Determine how you’ll
upload data