Lesson Code: SER-1106 (PREMIUM LESSON). What happens to serialized products when they leave the production facility, how change of ownership is accomplished and how compliance with the DSCSA and DQSA is achieved.

  • Category: Serialization


Having completed this e-Lesson, you will be able to:

  • 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'