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Complaint Management for Pharmaceutical Manufacturers
After completing this course, you will be able to identify the primary elements in an effective pharmaceutical complaint handling system. You will also recognize how to document complaint information as required by FDA regulations and understand the basic requirements for complaint evaluation and investigation. You will be able to recognize the types of complaints that must be reported to FDA according to the Adverse Drug Experiences regulations, and identify the importance of using statistical techniques to identify complaint trends that may indicate potential quality problems.
