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
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