Four Level Serialization Structure

Serialization and product tracking are essential tools in combating counterfeit drugs and ensuring patient safety within the pharmaceutical and biologics industries. This module introduces the concepts of serialization and product tracking, focusing on their regulatory framework, implementation strategies, and the technologies used to maintain traceability. It covers the importance of “Track and Trace” and “Authentication,” the role of packaging lines, and the stages involved in rolling out a serialization program. Key challenges, including equipment integration, data integrity, and international standards, are also addressed to help users navigate the complexities of implementing these systems.

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

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SKU: SER-1101-SPL01-EN Category: Packaging Tag: SER

Description
Keywords

Description

Learning Objectives:

Describe the four-level serialization corporate structure
Explain what is meant by ‘top-down’ generation and transmission of serial numbers
Describe the IT functions associated with each of the four levels of the serialization corporate structure

Learner Benefits:

Gain a Comprehensive Overview: Develop a clear understanding of the four-level serialization corporate structure, including the enterprise, site, packaging line, and machine/device levels.

Enhance Technical Knowledge: Understand how serial numbers are generated, stored, transmitted, and applied to packaging formats, ensuring product traceability and integrity throughout the supply chain.

Improve Practical Skills: Learn the IT functions associated with serialization at each level and how they support operations such as disaggregation, re-aggregation, and regulatory compliance.

Strengthen Compliance Competence: Equip yourself with the knowledge to ensure serialization processes meet regulatory requirements, including traceability obligations under laws like the Drug Supply Chain Security Act (DSCSA).

Reinforce Learning Through Interactivity:
Apply your learning through knowledge checks and explorations that reinforce understanding of the serialization process and its implementation.

Module Features:

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