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Industry Models for Designing Quality into Clinical Trial Processes for Operational Excellence

May 13-14, 2014
  • Philadelphia, Pennsylvania

Clinical Risk Management
and Quality by Design

MAY 13–14, 2014  |  PHILADELPHIA, PA

 

Industry Models for Designing Quality into
Clinical Trial Processes for Operational Excellence


What is QbD and why should I implement into clinical trials?


Quality by Design (QbD) is a practice long used in manufacturing that focuses on a holistic approach to quality -- and is now starting to become a focus in clinical trials.  Why?  The idea is to build quality into clinical processes from the beginning to ensure a better outcome for the patient, rather than managing quality issues as they arise.  Since much of the attrition found in clinical trials can be traced to the quality of initial study design and early development, implementing QbD can better set up your organization for success.


There is no doubt that it is much more effective to build quality into the process rather than manage quality in, but this requires an overhaul of processes/changing of SOPs and resources. Who has done this successfully and what can you take back to your organization in order to begin implementing QbD? Look no further. This conference shares industry case studies for QbD implementation into clinical trials.

 

Hear Expert Insights on:

  • Leveraging QbD best practices from manufacturing to clinical
  • Developing a process for QbD and continuous improvement
  • Utilizing QbD in protocol development
  • Applying QbD into the TMF process
  • Developing a QbD infrastructure to support risk based monitoring
  • Case studies from various size organizations on implementation