Lesson Code: PGI-780. The importance of accurate labeling in a pharmaceutical plant. What must be contained on a label, along with label distribution and reconciliation.
Lesson Code: PGI-770. Pharmaceutical packaging is introduced and pre-packaging checks required before a packaging operation can begin, are explained.
Lesson Code: SER-800 (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.
Lesson Code: SER-801 (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.
Lesson Code: SER-802 (PREMIUM LESSON). How serial numbers are generated, transactions associated with serial numbers, and how serial numbers are classified and sorted.
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.
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.
Lesson Code: SER-805 (PREMIUM LESSON). Events that require disaggregation along with procedures for performing disaggregation and reaggregation.
Lesson Code: SER-806 (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.