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A UL course

This program reviews the concept of change control by placing learners in the role of the change control manager. Participants learn to:

  • State the key elements of a change control program
  • Identify indicators of change
  • Follow change control regulations

The program shows how to identify groups involved in change control and describe the impact of change on product, processes, and people.

Featured topics

  • Regulatory requirements for change control
  • Steps in the basic model of change control
  • Indicators of an improper change
  • Elements of change control
  • Processing and packaging
  • US Food and Drug Administration notification

Who should attend?

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

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