Quality by Design and its Role in Trial Master File Management
Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). The ALCOA+C definition in ICH E6(R2) has created challenges and uncertainty within the industry with regard to its implementation in a TMF.
Fundamental to these new guidelines is the modernization of processes and technology to clinical trials with a focus on Quality by Design and risk-based management approaches that emphasize operational efficiencies and a movement away from an overreliance on retrospective practices.
In this session we explore:
Where are we today, where is quality (ALCOA+C) assured?
Quality by Design Regulatory Concepts
Setting the Stage for Quality by Design
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Chief Strategy Officer Phlexglobal
Consultant Risk Based Approach, Ltd
Manager of Clinical Operations PRA Health Sciences