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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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    Serialization and Product Tracking

    An overview of serialization and product tracking technologies, focusing on their critical role in the pharmaceutical and biologics industries. This module explains how serialization provides a unique identifier for each product, enabling full traceability from production to patient. It delves into the regulatory landscape surrounding serialization, explores key terms like “track and trace” and “authentication,” and outlines the steps involved in implementing a serialization program. With a particular emphasis on production line integration and GS1 standards, this module helps learners understand how serialization ensures product integrity and combats counterfeiting in the global supply chain.

    Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

      Duration: 30 Mins
    Grade: Premium Performance

    SKU: SER-1100-SPL01-EN Category: Tag:

    Description

    Learning Objectives:

    • Explain what is meant by ‘Serialization and Product Tracking’
    • Describe the regulatory background to serialization and product tracking
    • Explain why serialization and product tracking of medicines is needed
    • Explain the terms ‘Track and Trace’ and ‘Authentication’
    • List the typical components of a packaging line that is configured for serialization of prescription drug products
    • Summarize the stages involved in implementing a serialization and product tracking program

    Learner Benefits:

    • Understanding Serialization and Its Importance: Gain a comprehensive understanding of serialization and product tracking, including their role in preventing counterfeit drugs and ensuring patient safety across the pharmaceutical supply chain.
    • Knowledge of Regulatory Requirements: Learn about the various global regulations that mandate serialization and product tracking, and how they impact the lifecycle of medicines from production to distribution.
    • Practical Implementation Insights: Learn the stages of implementing a serialization program, from strategic planning and solution design to validation and scaling, ensuring smooth integration into existing packaging lines.
    • Familiarity with Production Line Integration: Understand how serialization technologies are incorporated into production lines, including the required equipment and system upgrades necessary for compliance with serialization standards.
    • Mastery of GS1 Standards: Understand the significance of GS1 standards for global traceability, ensuring consistency and compatibility across the supply chain for smoother international operations and regulatory compliance.
    Module Features:

        Animations
       Voice Over
        Knowledge Checks
        Assessments
       SCORM/AICC compatible
        Full Screen

    Keywords

    • Aggregation
    • Authentication
    • Barcodes
    • Counterfeit
    • Distribution
    • Drug Authentication
    • Counterfeiting
    • Electronic Tagging
    • GS1 Standards
    • Global Supply Chain (GSC)
    • Item Level Serialization
    • Product Lifecycle
    • Product Tracking
    • Regulatory Compliance
    • RFID
    • Serialization
    • Serialization Program
    • Supply Chain
    • Track and Trace
    • Validation
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