The document discusses serialized track and trace and solutions to business problems. It provides an agenda for a webinar on serialized track and trace, including vocabulary, standards, components, and regulations. It then covers various topics in depth, such as chain of custody, unique identification standards like GTIN and RFID, and SAP solutions for implementing auto-ID and item serialization.
Life sciences companies are in a complex market where healthcare costs have risen rapidly while reimbursements and margins have fallen to new lows. New genomic and large-molecule innovations are transforming therapies and improving patient outcomes. Targeted treatments for individuals with similar genetic markers continue to advance quickly. New collaboration models across partners, providers, and patients reinforce this trend.
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
Pharma Serialization: Managing the TransformationCognizant
Serialization is a method for the pharmaceuticals industry to deter counterfeit drugs from being sold or given to medical patients; it follows precepts developed by PIE, EPCIS, and PIMMS. Implementing serialization internationally is a technical challenge for pharma, requiring coordination at every step of the products' lifecycle.
Ignite 2015 Stefan Artlich - To Each Drug Package its Own Unique Number - Is ...Elemica
Stefan Artlich, Dir. Product Tracking and Authentication at Bayer Tech, focuses on how to develop and execute implementation roadmaps for pharmaceutical track-and-trace and how companies can comply regulations through better data capture and supply chain visibility gained from a business network.
It is mandatory for every medicine or pharma packaging to have a unique serial code or UID. Project is to build a web application that will provide tracking capabilities for the UID for pharma packaging of drugs. The track feature (TRACK n trace) will track the UID of each package by using vision based scanners, RFIDs, etc. and store the data into a local server. The server will be synced daily with a global server (we are looking for cloud based hosting platforms such as Windows Azure or amazon web services). We have to build the trace functionality (Track n TRACE) by building a web interface where a person with the UID can trace the shipment.
We have to keep historical records for as long as 10 years and build logic on basis of the UID state. We have to provide the details from the database as in when was this package manufactured, when was it shipped, etc. If the UID entered is faulty for example; it wasn’t ever manufactured or if it is over its expiration date then we have to generate corresponding errors and also maintain a log of such entries and send notification to the admins with details of IP, Geography or where the error generated.
Life sciences companies are in a complex market where healthcare costs have risen rapidly while reimbursements and margins have fallen to new lows. New genomic and large-molecule innovations are transforming therapies and improving patient outcomes. Targeted treatments for individuals with similar genetic markers continue to advance quickly. New collaboration models across partners, providers, and patients reinforce this trend.
The international community is at a cross-roads, keep allowing counterfeit medicinal drugs, or create legislation that prevents that from happening in the future. The legislation has been created, so how will you ensure compliance?
Pharma Serialization: Managing the TransformationCognizant
Serialization is a method for the pharmaceuticals industry to deter counterfeit drugs from being sold or given to medical patients; it follows precepts developed by PIE, EPCIS, and PIMMS. Implementing serialization internationally is a technical challenge for pharma, requiring coordination at every step of the products' lifecycle.
Ignite 2015 Stefan Artlich - To Each Drug Package its Own Unique Number - Is ...Elemica
Stefan Artlich, Dir. Product Tracking and Authentication at Bayer Tech, focuses on how to develop and execute implementation roadmaps for pharmaceutical track-and-trace and how companies can comply regulations through better data capture and supply chain visibility gained from a business network.
It is mandatory for every medicine or pharma packaging to have a unique serial code or UID. Project is to build a web application that will provide tracking capabilities for the UID for pharma packaging of drugs. The track feature (TRACK n trace) will track the UID of each package by using vision based scanners, RFIDs, etc. and store the data into a local server. The server will be synced daily with a global server (we are looking for cloud based hosting platforms such as Windows Azure or amazon web services). We have to build the trace functionality (Track n TRACE) by building a web interface where a person with the UID can trace the shipment.
We have to keep historical records for as long as 10 years and build logic on basis of the UID state. We have to provide the details from the database as in when was this package manufactured, when was it shipped, etc. If the UID entered is faulty for example; it wasn’t ever manufactured or if it is over its expiration date then we have to generate corresponding errors and also maintain a log of such entries and send notification to the admins with details of IP, Geography or where the error generated.
A Track and Trace system is a mass serialization solution for pharmaceutical and other industries that prints a unique identifying code onto each product after it has been packaged.
What is New in Track and Trace Technology?Angela Carver
In the distribution and logistics field track and trace is defined as the process of identifying past and current locations of inventory items. This inventory should be tracked at any level from ingredient to finished product and anywhere in between. Track and trace processes are supported through a variety of SCM technologies that help to provide real-time information on both location and status of these items as they move throughout the supply chain. A focus has been placed on track and trace due to the increasing complexity of governmental regulations. The government is becoming more active due to food recalls reaching their all-time high in 2013. On average, 6 recalls occur in the U.S. each day. These recalls impact up to 18.4 million products including pharmaceuticals, food and much more. This issue has sparked the focus on technology and automation throughout the supply chain.
These technologies are being used to manage the many moving pieces of the supply chain. In order to create a detailed, accurate audit trail needed to satisfy new regulations supply chain operators are implementing a variety of track and trace solutions including WMS, RFID and automated data collection devices.
SCM businesses handling food and pharmaceutical products have started to implement temperature indicators to track temperature, humidity and shock levels throughout the delivery process. These devices come in a variety of designs for flexible use. The data collected using temperature indicators can be transferred directly into inventory management software to develop a complete audit trail.
RFID functions in a similar way, passively tracking inventory as it moves throughout the supply chain. Radio frequency identification also helps to reduce the labor required to handle and process inventory. RFID is useful because it can track inventory at any level through the manufacturing process.
Warehouse management software is also a top tool used by SCM businesses focusing on track and trace because these powerful databases store all captured inventory data making it easily accessible to warehouse operators. Many top WMS systems are also developed to meet government regulations, taking the guess work out of track and trace.
To ensure your operation can meet regulatory requirements consider evaluating these technologies to bridge any gaps in technology capabilities. Learn more about new track and trace functionality and supply chain needs contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext 243.
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
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
Although data standards are not new, they have become an increased priority because without them healthcare organizations experience substantial inaccuracies and inefficiencies in their data.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
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.
Join this webinar to learn:
• What SPL is
• How it affects medical devices
• The relationship between SPL and UDI
• What medical device manufacturers can learn from the pharmaceutical industry
• How you can automatically create SPL documents with your standard labeling content
A Track and Trace system is a mass serialization solution for pharmaceutical and other industries that prints a unique identifying code onto each product after it has been packaged.
What is New in Track and Trace Technology?Angela Carver
In the distribution and logistics field track and trace is defined as the process of identifying past and current locations of inventory items. This inventory should be tracked at any level from ingredient to finished product and anywhere in between. Track and trace processes are supported through a variety of SCM technologies that help to provide real-time information on both location and status of these items as they move throughout the supply chain. A focus has been placed on track and trace due to the increasing complexity of governmental regulations. The government is becoming more active due to food recalls reaching their all-time high in 2013. On average, 6 recalls occur in the U.S. each day. These recalls impact up to 18.4 million products including pharmaceuticals, food and much more. This issue has sparked the focus on technology and automation throughout the supply chain.
These technologies are being used to manage the many moving pieces of the supply chain. In order to create a detailed, accurate audit trail needed to satisfy new regulations supply chain operators are implementing a variety of track and trace solutions including WMS, RFID and automated data collection devices.
SCM businesses handling food and pharmaceutical products have started to implement temperature indicators to track temperature, humidity and shock levels throughout the delivery process. These devices come in a variety of designs for flexible use. The data collected using temperature indicators can be transferred directly into inventory management software to develop a complete audit trail.
RFID functions in a similar way, passively tracking inventory as it moves throughout the supply chain. Radio frequency identification also helps to reduce the labor required to handle and process inventory. RFID is useful because it can track inventory at any level through the manufacturing process.
Warehouse management software is also a top tool used by SCM businesses focusing on track and trace because these powerful databases store all captured inventory data making it easily accessible to warehouse operators. Many top WMS systems are also developed to meet government regulations, taking the guess work out of track and trace.
To ensure your operation can meet regulatory requirements consider evaluating these technologies to bridge any gaps in technology capabilities. Learn more about new track and trace functionality and supply chain needs contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext 243.
Leveraging Oracle IDMP Enterprise Foundation Suite for Regulatory CompliancePerficient, Inc.
IDMP (Identification of Medicinal Products), which will soon be mandated by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), will enable stakeholders to obtain a comprehensive view of each individual product (e.g., ingredients, marketing and medicinal information, contacts), based on unique codes.
While the journey towards IDMP compliance can be incredibly challenging, industry-specific knowledge and systems play an integral role in meeting the new requirements.
In our webinar, we discussed how the Oracle IDMP Enterprise Foundation Suite can help you be ready in time.
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
Although data standards are not new, they have become an increased priority because without them healthcare organizations experience substantial inaccuracies and inefficiencies in their data.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
How to Review, Cleanse, and Transform Clinical Data in Oracle InFormPerficient, Inc.
When it comes to clinical trials, the consequences of bad data can be severe. Research and development becomes complicated and lives can be put at risk. The need for clinical data to be clean is critical for comprehensive reporting and analysis, ultimately enabling safer drugs and devices to be brought to market faster.
During our 30-minute, no-nonsense webinar, we discussed why and how organizations can leverage Oracle Health Sciences Data Management Workbench (DMW) to revitalize the clinical trial data captured in Oracle Health Sciences InForm.
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.
Join this webinar to learn:
• What SPL is
• How it affects medical devices
• The relationship between SPL and UDI
• What medical device manufacturers can learn from the pharmaceutical industry
• How you can automatically create SPL documents with your standard labeling content
OIMP Minotaur Software Barcode and Traceability Workshop judithkirkness
This slideshow is from a workshop about traceability and barcode decoding. It outlines the benefits of having an end to end traceability system, how to use traceability to gain a competitive advantage and how to decode GS1-128 Barcodes.
In fast-paced mass manufacturing, every product needs to be identified for traceability to avoid the slipping of faulty products into the hands of consumers.
Patent landscape efforts can get hampered either by voluminous patent search results or the perceived need to manually tag every single feature. It can increase uncertainty, costs, and complexity. Like chemical structure, biosequence, or freedom-to-operate patent searches, patent landscape searches have unique challenges. Delivering custom patent landscape analysis for effective decisions is beyond the skills of most end users. The final patent landscape report can vary depending on the allocated time and the optimal usage of advanced patent analytics tools by professional patent analysts (or by end-users). Many “state of the art” reports only provide patent search results with minimal analysis. Similarly, many automated “instant reports” only provide canned analysis and visuals that are too broad for POV analysis or corporate decision-making. This presentation describes the use of an efficient accelerated, intentional, and multifaceted (AIM™) patent landscape to alleviate these issues. The goal of an AIM™ patent landscape is to intentionally align scope with pending decisions. The results are delivered with appropriate level of analysis, including supporting charts, within an accelerated timeline of 2-3 weeks. AIM™ patent landscape analysis uses experienced patent analysts, a well-defined workflow process, and multiple best-in class patent data search, processing, and visualization tools. AIM™ patent landscapes are ideal in patent portfolio benchmarking efforts and delineating white space opportunities for well-defined projects.
Barcode & RFID Convergence: Enabling Greater Visibility Through StandardsVDC Research Group
This webcast was presented by VDC Research on the convergence of Barcode and RFID technologies on the GS1 US Visibility Framework.
Barcode is the dominant track and trace technology on the planet today and its value proposition is being extended by the more automated features of RFID. While these two technologies are often viewed as competitive, they are actually complimentary, and organizations are realizing the best of both worlds when they use GS1 standards as the framework for integrating RFID to improve their business processes.
Members of GS1 US and/or EPCglobal US will see that they not only have the foundation for enhanced visibility solutions, but they can implement them in a more cost effective and timely manner - all while realizing the benefits of building those solutions on a common architecture.
The Value of User and Data Centricity Beyond IoT Devices: Stein Myrseth and G...ForgeRock
Presented by Stein Myrseth, Senior Technology Solutions Director of ForgeRock and Gerhard Zehethofer, VP or Industries (IOT & Manufacturing) present at Identity Live in Austin in 2018
Maintenance and repair of plant equipment, whether for operational or safety reason, whether scheduled or unplanned, is a critical but time-consuming task. Tego offers an unprecedented RFID asset visibility solution for oil and gas companies. The benefit it real-time operational and safety equipment information and certificates stored on the equipment itself.
Thank you for checking out our Oil and Gas application brochure. For more information, please visit our website at http://tegoinc.com/
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
At Techbox Square, in Singapore, we're not just creative web designers and developers, we're the driving force behind your brand identity. Contact us today.
[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
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As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
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Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
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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.
Serialized track and trace. Is it a requirement you need to conform to or need?
1. A member of The Business Maturity Group
Solutions to Business Problems
Serialized track and trace. Is it a requirement you
need to conform to or need
May 23rd, 2013