Serialization

Serialization and Product Tracking

Lesson Code: SER-1100 (PREMIUM LESSON). An overview of serialization and product tracking including the commercial and regulatory drivers, the technologies involved and the process of implementing a serialization and product tracking solution.

Four Level Serialization Structure

Lesson Code: SER-1101 (PREMIUM LESSON). An overview of serialization architecture in the pharmaceutical industry. It describes the four levels of a serialization system and the IT functions associated with each.

Serial Number Generation

(Back Catalog) Lesson Code: SER-802 (PREMIUM LESSON). How serial numbers are generated, transactions associated with serial numbers, and how serial numbers are classified and sorted.

Serial Number Transmission

(Back Catalog) Lesson Code: SER-803 (PREMIUM LESSON). How serial numbers are transmitted from point of origin, through the different levels to where they are printed on packaging. It also describes the function of individual devices on the packaging lines.

Serialization - Aggregation and Error Management

(Back Catalog) Lesson Code: SER-804 (PREMIUM LESSON). How aggregation in serialization is performed, along with aggregation-related concepts such as parent-child relationships and error management.

Serialization - Exception Events, Disaggregation, and Reaggregation

(Back Catalog) Lesson Code: SER-805 (PREMIUM LESSON). Events that require disaggregation along with procedures for performing disaggregation and reaggregation.

Serialization and the Supply Chain

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.

Labeling

Labeling

Lesson Code: PGI-1280. This e-Lesson is aimed at manufacturing personnel who require an overview of labeling principles and procedures in pharmaceutical and biologics facilities.

Packaging

Primary Packaging

Lesson Code: PGI-1271. This e-Lesson is aimed at manufacturing personnel who require an overview of the principles of primary packaging and the processes involved.

Secondary and Tertiary Packaging

Lesson Code: PGI-1272. This e-Lesson is aimed at manufacturing personnel who require an overview of the principles of secondary and tertiary packaging and the processes involved in each.