Complaint Management for Pharmaceutical Manufacturers

There are specific requirements regarding how companies must receive, investigate, document, file, and report customer complaints. This course identifies the primary elements in an effective pharmaceutical complaint handling system. Topics in this course include: System Elements, Complaint File, Investigation, Adverse Drug Experiences, and Complaint Analysis. After completing this course, learners will be able to identify the key elements in building an effective pharmaceutical complaint handling system.

After this course learners will be able to identify the primary elements in an effective pharmaceutical complaint handling system. recognize how to document complaint information as required by fda regulations. recognize the basic requirements for complaint evaluation and investigation. recognize the types of complaints that must be reported to fda according to the adverse drug experiences regulations. identify the importance of using statistical techniques to identify complaint trends that may indicate potential quality problems.