Computerized Systems Inspections in the Pharmaceutical Industry

This course explores how FDA personnel recognize the critical aspects of computerized systems in the pharmaceutical industry during Pre-Approval and routine current Good Manufacturing Practices (cGMP) inspections. The course explains how computerized systems are used in the pharmaceutical manufacturing process and provides an approach to inspecting these systems. Topics in this course include: Use, Inspectional Approach, Focus, and Regulations and Guidelines. After completing this course, learners will be able to recognize where computerized systems are used in the pharmaceutical manufacturing process. Leaners will also be able to recognize FDA’s approach to inspecting computerized systems. Learners will also be able to identify the levels of review that may be used and what comprises each level.

After this course learners will be able to recognize where computerized systems are used in the pharmaceutical manufacturing process. recognize fda’s approach to inspecting computerized systems. identify the levels of review that may be used and what comprises each level.