Cleaning Validation
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Gen AI in Quality
Harsh Thakkar, CEO Qualtivate
Electronic Batch Record
Shirish G Belapure, Ex- MD Zydus
Gen AI in Pharma
with Prashant Sharma, CTO - ZYDUS
Root Cause Analysis
with Ganadhish Kamat, Ex - Dr Reddy's, Lupin
FDA Inspections
with Dr. Abhay Gaitonde, Ex- Merck, Mylan, Alembic
Risk Mitigation in Pharma
with Mr Subhrangshu Chaudhury, VP Quality at Centaur Pharmaceuticals Pvt. Ltd.
Root Cause Investigations
with Mr. Rajesh T, Digitization Head, Dr. Reddy’s
Role of AI in Pharma manufacturing
with Dr. Rajiv Desai Ex VP Global QA, Lupin
Gen AI in Quality
Harsh Thakkar, CEO Qualtivate
Electronic Batch Record
Shirish G Belapure, Ex- MD Zydus
Gen AI in Pharma
with Prashant Sharma, CTO - ZYDUS
Root Cause Analysis
with Ganadhish Kamat, Ex - Dr Reddy's, Lupin
Cleaning Validation
with Thomas Altmann, Global Technical Manager at Ecolab
FDA Inspections
with Dr. Abhay Gaitonde, Ex- Merck, Mylan, Alembic
Risk Mitigation in Pharma
with Mr Subhrangshu Chaudhury, VP Quality at Centaur Pharmaceuticals Pvt. Ltd.
Root Cause Investigations
with Mr. Rajesh T, Digitization Head, Dr. Reddy’s
Role of AI in Pharma manufacturing
with Dr. Rajiv Desai Ex VP Global QA, Lupin
Leucine's AI Based solutions for
Cleaning Validation
In this episode of the AI Pill for Pharma, our esteemed guest is Mr. Thomas Altmann, Global Technical Manager at Ecolab.
Mr. Altmann has 20+ years of experience in pharmaceutical, biotechnology and personal care cleaning process optimization and validation
In this episode, Altmann pinpoints incorrect limit setting as the paramount mistake in the industry, emphasizing that the misunderstanding of health-based exposure limit calculations leads to inefficiencies and potential safety risks. He critiques the reliance on outdated methods like the 10 PPM criteria and LD 50-based calculations, advocating for a risk-based approach that ensures safety without stifling innovation. He underscores the importance of setting operational limits well below health-based exposure limits to allow room for action and ensure absolute safety.
… and more. Tune in!
