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FDA Inspections

40:00
Operational Excellence in Pharma

Operational Excellence in Pharma

Gresh Kumar, Head of Operational Excellence at Syngene

44 mins
Gen AI in Quality

Gen AI in Quality

Harsh Thakkar, CEO Qualtivate

36 mins
Electronic Batch Record

Electronic Batch Record

Shirish G Belapure, Ex- MD Zydus

47:09
Gen AI in Pharma

Gen AI in Pharma

with Prashant Sharma, CTO - ZYDUS

47:22
Root Cause Analysis

Root Cause Analysis

with Ganadhish Kamat, Ex - Dr Reddy's, Lupin

50:00
Cleaning Validation

Cleaning Validation

with Thomas Altmann, Global Technical Manager at Ecolab

43:00
Risk Mitigation in Pharma

Risk Mitigation in Pharma

with Mr Subhrangshu Chaudhury, VP Quality at Centaur Pharmaceuticals Pvt. Ltd.

36 mins
Root Cause Investigations

Root Cause Investigations

with Mr. Rajesh T, Digitization Head, Dr. Reddy’s

36 min
Role of AI in Pharma manufacturing

Role of AI in Pharma manufacturing

with Dr. Rajiv Desai Ex VP Global QA, Lupin

30 Min Listen
BLOG
May 22, 2024

Operational Excellence in Pharma

Gresh Kumar, Head of Operational Excellence at Syngene

BLOG
Nov 4, 2024

Gen AI in Quality

Harsh Thakkar, CEO Qualtivate

BLOG

Electronic Batch Record

Shirish G Belapure, Ex- MD Zydus

BLOG
Mar 20, 2024

Gen AI in Pharma

with Prashant Sharma, CTO - ZYDUS

BLOG

Root Cause Analysis

with Ganadhish Kamat, Ex - Dr Reddy's, Lupin

BLOG
Feb 13, 2024

Cleaning Validation

with Thomas Altmann, Global Technical Manager at Ecolab

BLOG
Feb 21, 2024

FDA Inspections

with Dr. Abhay Gaitonde, Ex- Merck, Mylan, Alembic

BLOG
Jan 27, 2024

Risk Mitigation in Pharma

with Mr Subhrangshu Chaudhury, VP Quality at Centaur Pharmaceuticals Pvt. Ltd.

BLOG
Jan 27, 2024

Root Cause Investigations

with Mr. Rajesh T, Digitization Head, Dr. Reddy’s

BLOG
Jan 27, 2024

Role of AI in Pharma manufacturing

with Dr. Rajiv Desai Ex VP Global QA, Lupin

Leucine's AI Based solutions for

350+ pharma facilities globally

use Leucine

to stay compliant.

350+ Pharma

Facilities Globally

use Leucine

to stay compliant.

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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. 

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.

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.

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