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Overview

A UL EduNeering course

This course was designed by ISPE and EduNeering, Inc. in cooperation with the US Food and Drug Administration (FDA) Office of Regulatory Affairs to help FDA personnel recognize the critical aspects of computerized systems in the pharmaceutical industry during pre-approval and routine good manufacturing practices inspections. The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these computerized systems.

Featured topics

  • Computerized systems in the pharmaceutical industry
  • Investigator’s approach to computerized systems
  • The focus of the investigator’s review

Who should attend?

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

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