This course has been designed by ISPE and EduNeering, Inc. in cooperation with the FDA/ORA, to assist FDA personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry during Pre-approval and routine GMP inspections.  The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these computerized systems.  After completing this course, you should be able to recognize where computerized systems are used in the pharmaceutical manufacturing process, recognize FDA’s approach to inspecting computerized systems, and identify the levels of review that may be used and what comprises each level. 

Topics include:
      ·          How computerized systems are used in the pharmaceutical industry
      ·          How an investigator should approach computerized systems
      ·          The focus of the investigator’s review 

Linda Belmont at DIA