Writing Controlled Documents in a cGMP Environment



Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for designing and writing controlled documents, with the goal of minimizing risks for misinterpretation, and errors in communication. Participants will also gain an understanding of the associated regulatory requirements and will learn fundamental concepts of document control.


  • Recall the role of regulatory requirements and their history in the cGMP workplace
  • Describe documentation required for a company’s Quality Management System (QMS)
  • Identify strategies for designing and writing controlled documents
  • Understand fundamental concepts of document control
  • Write a standard operating procedure (SOP)
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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 2 hours
  • Skill level All Levels
  • Wet Lab No
  • Max Students 24
  • Assessments Yes