Managing the Logistics of a Medical Device Audit

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Today’s medical device manufacturers navigate a complex ecosystem of regulatory compliance, both domestically and abroad. Manufacturers are subject to varying regional regulations with unique requirements and specific guidelines. An overarching logistics strategy can be applied to all plants despite the regional variations.

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Managing the Logistics of a Medical Device Audit

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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.

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This presentation is designed to take an overview of global supply chain logistics, both in terms of today's supply chain and in the demand flow management process, so you can know how to make the most of this powerful tool. You've probably heard something about these topics. You may even be vaguely familiar with them. But how much do you really know about their strategic importance and the specific benefits you can gain from having a solid understanding of them? Here's the best way to investigate global supply chain logistics and the impact it can have on your organization. You will have the opportunity to explore a variety of logistics areas , extrapolate their meanings in ways that are appropriate for strategic planning, and apply the techniques needed to make it all work for your organization. Your business needs and technology are in a constant state of rapid-fire change, but you can count on one thing remaining constant: the need to align logistics strategically with your market needs in order to gain a competitive advantage. This alignment requires building a supply and demand system that truly helps you respond to worldwide changes in sourcing and ever-shifting customer demand. What is the potential effect that global trade management will have on your supply chain? How do you convert digital value inputs into logistics value-added outputs? How can you harness the power of global supply chain logistics as a significant force in the execution of your corporate strategy? How can you gain the information you need to translate abstractions into concrete benefits through supply chain management and continuous flow distribution?

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On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One. Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit. Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.

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Should Costing is a systematic process that enables cost reduction from the conceptualization stage through the product life-cycle. Maintaining competitiveness within the aerospace industry is highly dependent on an organization’s ability to reduce product costs and delivery cycle times. However, the industry as a whole continues to face challenges in managing product costs from the inception stage through the very long life-cycle of its products. Aerospace organizations produce complex products that source between 50-70% of their components from suppliers. To eliminate significant costs prior to production, organizations must first identify the major cost drivers of components that are designed, manufactured and procured. Identifying these cost drivers can aid in supplier selection, effective negotiation and advanced segmentation.

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