As the global regulatory landscape incorporates more and more requirements for risk assessments and risk-based approaches, the importance of quality risk management (QRM) continues to grow. QRM is also a hot topic at many regulatory inspections and agencies often actively review risk assessments in critical areas, e.g., cross-contamination. A solid QRM program and integration of QRM into the appropriate pharmaceutical quality systems help a company to be compliant, proactively identify risks to product quality before they become issues and reduce the number of manufacturing deviations. While building a robust QRM program and executing individual risk assessments, there are some common pitfalls teams come across that can lead to ineffective and inefficient QRM results.
This session will explore a variety of real-world situations encountered during the execution of quality risk assessments and their associated impact if they are not handled appropriately. This session will also cover solutions used in industry to prevent and/or course correct if these pitfalls present themselves.
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