Wednesday FoREMS: Failure Mode and Effect Analysis: Identifying and Managing Risks That Appear Beyond Your Control
January 12, 2011
Failure Mode and Effect Analysis: Identifying and Managing Risks That Appear Beyond Your Control
Every medication has benefits and risks that need to be managed. Traditionally, the risks of focus for pharmaceutical manufacturers and FDA were the “intrinsic” adverse events of medications. As regulators and the public have elevated their expectations about the proactive management of risks, manufacturers have begun to focus on the risks associated with the care delivery process that could expose patients to medication AEs. For example, if a pharmacist doesn’t counsel a patient about a serious drug-drug interaction, what are the consequences?
The question for manufacturers is how to identify and manage risks associated with product use in the “real” world that appear to be beyond the control of the manufacturer? One solution is through a proven, systematic and scientific methodology such as Failure Mode and Effects Analysis (FMEA). In this webinar, two experts on the use of FMEA in pharmaceutical risk management will:
- Describe the scientific methods
- Illustrate the templates and work flow for conducting the analysis
- Review selected portions of a case example
- Show how the output integrates into the overall design process
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