Course curriculum

  • 1

    Overview

    • cGMP Training Overview

    • Course Outline

    • Before we begin...
  • 2

    Purpose & Definitions

    • Purpose

    • Definitions
  • 3

    Regulatory Requirements

    • Compliance

    • Cost of Non-compliance
  • 4

    Applying cGMP Principles

    • cGMP Documentation and Procedures

    • Responsibility for Quality Product

    • Organization and Personnel

    • Buildings and Facilities

    • Material Control

    • Process Controls

    • Packaging and Labeling Controls

    • Storage and Distribution

    • Quiz
  • 5

    Pharmacovigilance

    • Complaint Handling
  • 6

    Virtual Manufacturers

    • cGMP Requirements for VM
  • 7

    Summary

    • Critical cGMP Requirements

    • Quiz
  • 8

    Risks

    • Manufacturing Risks

    • Doing the Right Thing

    • Quiz