Systems Based Drug Inspections

FDA has a series of compliance programs that provide guidance and instructions to help meet FDA regulations for pharmaceutical manufacturers. This course describes FDA’s Drug Manufacturing Inspections program. Topics in this course include: Guidance, Systems, Inspections, Quality, Facilities and Equipment, Materials, Production, and Laboratory Control. After completing this course, learners will be able to recognize what can happen if a firm is not following FDA regulations.

After this course learners will be able to recognize the guidance provided by fda for investigators inspecting drug firms for gmp compliance. recognize the guidance provided in cp 7356.002 for conducting inspections, sampling, analyzing samples, and evaluating compliance.