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Pharmaceuticals, Medical Devices

Failure Investigations for Pharmaceutical Manufacturers

About the Course

Conducting a failure investigation in a pharmaceutical environment is a complex process. If the root cause of a failure is not properly identified, there may be compliance failures or missed opportunities for improvement of product quality or even a risk to patient safety. An effective system for conducting failure investigations can provide a means for preventing recurrences. It is for these reasons that it is important for those in a pharmaceutical manufacturing environment to know the characteristics and requirements of a good failure investigation. This eLearning course will familiarize the learner with GMP regulations regarding failure investigations and the key components of a good investigation. Additionally, the learner will also be able to identify how to determine the “root cause” of a failure and recognize the importance of corrective actions and follow-ups to failure investigations.