Module 1:
Introduction and Background

  • Greetings!
  • Background
  • Introductions
  • Goals
  • Overview: Discovery and Pre-Clinical Phase
  • Overview: Clinical Development Phase
  • Whiteboard Review
  • Drug Development Phases
  • Definition of CGMPs
  • Multiple Choice Self-Test
  • 21 CFR Parts 210 and 211
  • Purpose of CGMPs
  • Practical Laboratory Definition of CGMPs
  • Whiteboard Review
  • The Language of Laboratory Compliance
  • Multiple Choice Self-Test
  • Fill in the Blank
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