FDA Inspections

In this episode of AI Pill for Pharma, our esteemed guest is Dr. Abhay Gaitonde, Ex Merck, Mylan, Alembic

Dr. Gaitonde has 20 years of rich and diverse experience in the pharmaceutical industry. 

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In this episode, he talks about FDA INSPECTIONS in Pharma. He shares his insights on:

✅ Inspectors' deeper objectives, looking for what might be missing or hidden.

✅ The focus areas of PAI and GMP inspections, from data integrity to quality management systems.

✅ The cultural and operational challenges within the industry that affect inspection outcomes.

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Dr. Gaitonde challenges the conventional wisdom that FDA inspections are mere tick-box exercises. He argues that inspectors delve much deeper, looking for the integrity and readiness of operations. Artificial intelligence holds the promise of revolutionizing various aspects of pharmaceutical manufacturing and quality assurance. This extensive section will explore the current and potential applications of AI in the industry, from enhancing data integrity to automating quality control processes, and the implications for regulatory compliance and inspection readiness. The FDA has begun to recognize the potential of AI in pharmaceutical manufacturing. This addresses the hurdles pharmaceutical companies face in integrating AI technologies, including cost, workforce training, and the evolving nature of AI, which necessitates a dynamic approach to validation and regulatory compliance. It offers a forward-looking perspective on how pharmaceutical companies can navigate the evolving regulatory landscape and harness the power of AI to enhance quality, efficiency, and compliance.