Skip to content
Skillpad_Logo

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.

Ireland
USA
Canada
+353-1-687-0400
+1-973-588-4884
+1-514-316-2339

Get In Touch

    Serialization and the Supply Chain

    An overview of the serialization and product tracking processes as they pertain to the pharmaceutical supply chain, focusing on the key stages that occur once serialized products leave a regulated production facility. The module covers the regulatory framework, including the Drug Supply Chain Security Act (DSCSA), and explains the necessary steps for achieving compliance with serialization requirements. Learners will explore the concepts of “Track and Trace” and “Authentication,” as well as the challenges faced when products change ownership within the supply chain. Emphasis is placed on the critical manual operations involved in serialization, such as disaggregation, rework, and product recall.

    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-1106-SPL02-EN Category: Tag:

    Description

    Learning Objectives:

    • Outline key aspects of the Drug Supply Chain Security Act (DSCSA) and the European Union Falsified Medicines Directive (EUFMD)
    • Define the terms: “Transaction Information”, “Transaction History”, and “Transaction Statement”. (Also known as “TI / TH / TS”)
    • Describe key aspects of Supply chain dynamics such as ownership, supply chain mapping and ‘Free on Board’.
    • Explain the difference between ‘authentication’ and ‘track & trace’.

    Learner Benefits:

    • Comprehensive Understanding of Serialization Processes: Learn the full scope of serialization and product tracking, from initial packaging and serial number generation to movement through wholesalers, distributors, and dispensers, all the way to the end user.
    • Knowledge of Regulatory Compliance: Gain insight into the Drug Supply Chain Security Act (DSCSA) and its impact on serialization practices. Understand how to ensure compliance with regulatory standards related to the traceability of drug products.
    • Expertise in Track and Trace Systems: Master the concepts of “Track” and “Trace,” and learn how these systems ensure accurate product tracking across the supply chain, addressing both current location and historical movements.
    • Practical Insights into Manual Serialization Operations: Understand the manual operations critical to maintaining product integrity, including the decommissioning of serial numbers, product disaggregation, and handling situations like product recalls or suspected tampering.
    • In-depth Knowledge of Ownership Transitions in the Supply Chain: Explore the complexities of ownership transfer within the pharmaceutical supply chain, including challenges and best practices for tracking changes in ownership from manufacturer to dispenser.
    Module Features:

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

    Back To Top
    Your Cart

    Your cart is empty.