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cGMP Introduction

In this course, the student will learn the basic regulatory requirements for the manufacturing and control of pharmaceutical drugs and devices. We discuss topics such as:

  • Where and when regulations apply
  • Basic philosphy of cGMP
  • Regulatory bodies
  • cGMP regulations - FDA, EU and ICH
  • The Barr Laboratories case
  • Pharmacopoeias
  • Regulatory inspections
  • The quality control unit
  • Standard operating procedures (SOP)
  • Documentation
  • Training
  • Change control
  • Validation
  • Individual responsibilities
Tthe course allows for plenty of discussion and questions.