PDA/FDA ICH Q10 Implementation Workshop – Practical Application of QRM 2014

Learn and share experiences with the implementation of the two ICH Q10 enablers: Quality Risk Management (QRM) and Knowledge Management (KM) in the Pharmaceutical Quality System (PQS). It's been 5 years since ICH Q10 was published. In this workshop, in the series of 'ICH Q10 FDA/PDA Learning Workshops' (previous topics Management Responsibility (2012) and Effective Investigations (2013)) we will explore how well companies have implemented the two enablers into their quality system. While many companies have implemented efficient QRM processes into their PQS, there are still some opportunities to pursue based on current inspectional findings and drug shortages data. When it comes to KM, many companies are still challenged by how well KM can be institutionalized. With a focus on the PQS, we will discuss and share best practices for QRM and KM implementation and active use in companies. We will cover several case studies and in breakout sessions we will discuss ways to further enhance QRM and KM use in our industry to ensure product realization, effective controls and facilitating continual improvement.