Índice

  • 01

    COURSE INFORMATION

  • 02

    Introduction and Scope

    • Heavy metals vs ICH Q3D

    • Objective and Content

    • Dates and Scope

    • Typology and PDEs

  • 03

    Steps to follow

    • Identification

    • Analysis

    • Evaluation

    • Control
  • 04

    Implementation Approaches

    • Enfoques de implementación

  • 05

    Necessary Documentation

    • Documentación necesaria

  • 06

    Source Risk Asses

    • Services

    • Manufacturing Process

    • Conditioning Material

    • Components: Excipients and API

  • 07

    Presentation of Results

    • Presentation of Results

  • 08

    Life Cycle

    • Life Cycle

  • 09

    Case Studies

    • Case 1: Capsules with film-coated microtablets

    • Case 2: Effervescent Tablets

    • Case 3: Film-coated tablets

    • Case 4: Vitamin B12 Tablets