Root Cause Analysis
In this episode of AI Pill for Pharma, our esteemed guest is Ganadhish Kamat, Ex - Quality Head at Dr. Reddy's, Lupin, He is a stalwart of the pharma industry. Dive deeper with Ganadhish Kamat and Vivek Gera as they dissect the critical gap in pharmaceutical root cause analysis:
✅ The often overlooked link between product knowledge and process understanding.
✅ The rush to meet filing deadlines leading to a superficial grasp of crucial data.
✅ How this oversight significantly impacts product quality and efficiency post-approval.
Ganadhish emphasizes the importance of a comprehensive approach, akin to a well-oiled machine, where every component's role is understood and optimized for peak performance.
Top FDA observations Cleaning Validation in Pharma Industry
Build understanding on the recent FDA observations in cleaning validation.
-min.png)
.webp)
.webp)
