Pharmaceutical Digital Quality Transformation and Excellence

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https://www.podbean.com/eau/pb-gjrkd-...

Pharmaceutical Digital Quality Transformation and Excellence
What does it take to build world-class pharmaceutical quality in the digital era?In this episode, we unpack how Pharma 4.0 is redefining quality—from reactive compliance to a proactive, predictive, fully connected ecosystem that protects patients, accelerates operations, and strengthens regulatory confidence.
Drawing on industry frameworks and real-world implementation insights, we explore the full transformation journey:

The rise of Quality 4.0 and science-based Quality by Digital Design
How eQMS, digital batch records, automated QC, and AI-driven analytics reshape quality workflows
Real-time monitoring, CPV, digital twins, predictive risk management, and AI-enhanced SPC
Integrating data integrity, governance, and ALCOA+ principles into every process
Achieving excellence through continuous improvement and cross-functional digital culture

You’ll hear practical strategies for:✔ Selecting and validating digital QMS platforms✔ Deploying robotics, PAT, and automated QC systems✔ Implementing predictive analytics and AI-assisted process control✔ Transforming documentation, audit readiness, and regulatory compliance✔ Building sustainable quality governance and organizational capability
Whether you lead quality, operations, manufacturing, data, or digital transformation, this episode provides a comprehensive roadmap for turning digital quality into a strategic advantage—delivering safer products, faster cycles, and stronger performance across the pharma value chain.