Failure Investigations for Pharmaceutical Manufacturers

An effective system for conducting failure investigations can provide a means for preventing recurrences. This course will familiarize the learner with GMP regulations regarding failure investigations and the key components of a good investigation. Topics include: Failures, Root Cause, Corrective Actions, Follow-Up, and Investigation Reports. After completing this course, you will be able to identify the failure investigation process. You will be able to recognize how GMP regulations address failure investigations and the key components of a good investigation. You 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.

After this course learners will be able to identify the failure investigation process. recognize how gmp regulations address failure investigations and the key components of a good investigation. identify how to determine the root cause of a failure. recognize the importance of corrective actions and follow-ups to failure investigations.