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1869 total results
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PDG, HDA, and GS1 Hold Critical Workshop on DSCSA 2023 Compliance Exceptions Management
TraceLink experts share deep insights into serialized product operations and network data management considerations with industry workshop participants.
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Ensure On-Time Drug Shipments: How to Quickly Replace Your Serialization System with the Leading Track-and-Trace Platform
Is your current serialization and compliance solution provider putting on-time shipments at risk? Tired of poor support services, a lack of communication, weak functionality, and high costs?
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Education
US Product Track Serialized Data Exchange Instructor Session
Learning Objectives Configure your system to exchange serialized data in Product Track. Describe partner setup. Review product requirements.…
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Partnership for DSCSA Governance (PDG) Interoperability Blueprint Publication
Leading industry-wide collaboration forum and workgroup publishes an extensive set of interoperability guidelines and frameworks for meeting DSCSA 2023 requirements.
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Track and Trace for Phase 3 Pharmaceutical Manufacturers
Manage all global track-and-trace mandates with a proven serialization solution suite used by more than 80% of pharmaceutical companies launching their first product to market.
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DSCSA 2023 Introduces New Product Verification Requirements for Pharmaceutical Manufacturers
When the final phase of the U.S. Drug Supply Chain Security Act (DSCSA) goes into effect on November 27, 2023, it will mandate significantly expanded product verification requirements for pharmaceutical manufacturers.
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Partner
Booster Autotech
Booster is committed to introducing European and American high-quality pharmaceutical equipment and packaging machine. In addition to providing…
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A Wholesale Distributor's Point of View: What is Required from Manufacturers for DSCSA 2023?
Ashley DeFlice, Regulatory Affairs Specialist at wholesale distributor Henry Schein, explains why pharmaceutical manufacturers must act with urgency and prepare for DSCSA 2023 now.
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DSCSA 2023: What It Means for the Pharma Supply Chain—and for Your Company
This article will delve into DSCSA 2023, its goals, and how you can get started with TraceLink.
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U.S. DSCSA 2023 Readiness: Rapid Path to Upgrading for EPCIS
Learn how to activate your TraceLink Product Track solution for DSCSA-compliant EPCIS data exchange.
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Education
Warehouse Operations with Smart Inventory Tracker eLearning Course
Learning Objectives Describe how Smart Inventory Tracker supports the traceability, receiving, and distribution requirements for compliance.…
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IBERFAR: Partnering with TraceLink for FMD and Digital Integration
Hear the IBERFAR team explain how they mastered serialization and FMD with TraceLink.
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The 5 Levels of Serialization and Information Management
As you begin to tackle regulatory compliance, you’ll hear references to the different “levels” of serialization. If you lack components at any level, your business is at risk.
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Virtual Manufacturer Streamlines Software Validation with AVM
Read why a leading oncology-focused biotechnology company chose TraceLink's Automated Validation Manager (AVM) to reduce software validation complexity.
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Digital Transformation of the Supply Chain eBook
Industry snapshot: Find out how digital transformation will lead to fewer drug shortages and better patient outcomes.
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EU FMD Express: The Perfect Partner for Virtual Pharma
Discover why this small French pharma company chose TraceLink for a cost-effective compliance solution.
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New FDA Guidance: Verification Systems for DSCSA
View a summary of the FDA's thoughts on the DSCSA verification requirements.
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As DSCSA Manufacturer Serialization Enforcement Begins, More Than 250 TraceLink Customers Are Live
As full FDA serialization enforcement begins on November 28, TraceLink has helped more than 250 manufacturing companies go live with serialization.
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Saleable Returns Verification: What You Need to Know About Enforcement Discretion
See why companies should move ahead with a saleable returns solution even with FDA enforcement discretion.
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Preparing for Russia Compliance: 6 Critical Considerations
Companies that sell product into Russia need to focus on six critical considerations, and understand how Russia challenges differ from those of FMD and DSCSA.
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Global Compliance: A Blueprint for Meeting Local Market Challenges
Watch this video to see why companies must be able to comply with regulations and operationalize global compliance solutions across diverse markets.
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Company Switches to TraceLink After Two Unproven Providers Fail
Learn why a pharma company and CMO's first two choices failed to develop a successful EU FMD solution.
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Improving Healthcare Operations and Patient Safety with Edge Data
Find out how hospitals and pharmacies can use edge data capture to improve both inventory management and patient outcomes.
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EU FMD: The Risks of Product Stockpiling
Stockpiling product to delay EU FMD compliance is a temporary approach that offers no long-term value—and carries significant risks.
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McKesson Q&A: The Challenge of Saleable Returns Verification
Read how McKesson is getting ready for the DSCSA saleable returns verification requirement, and how to handle DSCSA compliance in the face of it.
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French Pharma Selects TraceLink for Smooth LMS Integration, Lower Costs
Learn what issues one pharma company faced with other solution providers, and why it ultimately chose TraceLink for EU FMD compliance.
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Automating Validation with Every Release
Watch these brief videos to quickly understand how serialization compounds validation demands, and how to replace manual processes with automation.
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Preparing for Saudi Arabia Compliance Reporting
TraceLink SVP of Product Marketing, Lucy Deus, provides an in-depth review of the January 2019 Saudi reporting requirements for pharma supply chains.
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Delivery Issues and High TCO Prompt Generics Pharma to Switch to TraceLink
Needing to get control of spiraling infrastructure costs, one pharma switched to TraceLink for serialization. Find out more.
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From Crypto Codes to Complex Reports: Expert Advice on TraceLink’s Russia Compliance Solution
Get expert advice on meeting Russia's complex track and trace requirements for pharmaceutical companies. Learn how TraceLink can help.
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