Índice

  • 01

    COURSE INFORMATION

  • 02

    Overview of the nitrosamine scenario: technical and regulatory background

    • Nitrosamines and cancer

    • Present day and Risk Evaluation
  • 03

    Nitrosamines chemistry - confirmed root causes

    • N-Nitrosamines

    • Where does amine moiety comes from?
  • 04

    Identified root causes of nitrosamine contamination

    • Evolution of the problem

    • Root Causes
  • 05

    Risk evaluation of drug problems

    • Nitrosamine impurities risk assessment

    • Risk evaluation - Potencial sources

    • Risk evaluation - Synthesis of the API

    • Risk evaluation - Excipient matrix

    • Risk evaluation - Manufacturing process of final product

    • Risk evaluation - Packaging materials

    • Risk evaluation - Final product shelf-life
  • 06

    EVALUATION

    • Exam