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11th Advanced GMP Workshop

Virtual October 8, 2026

Flyer

Agenda

Speakers

Sudarshan Jain

Sudarshan Jain

Secretary General, Indian Pharmaceutical Alliance

Nilesh Gupta

Nilesh Gupta

Managing Director, Lupin and Chair, IPA Quality Forum

Gregory Smith

Gregory Smith

Country Director, India Office, US FDA

Dr. Rajeev Singh Raghuvanshi

Dr. Rajeev Singh Raghuvanshi

Drugs Controller General of India

Dr. Rafeeq Habeeb

Dr. Rafeeq Habeeb

Regulatory Specialist, India Office, OGPS, US FDA

Shirish Ambulgekar

Shirish Ambulgekar

President and Global Quality Head, Alkem Laboratories

Dr. Damodharan Muniyandi

Dr. Damodharan Muniyandi

Chief Quality Officer, Sai Life Sciences

Abhijit Kulkarni

Abhijit Kulkarni

Vice President, Corporate Quality Assurance, Lupin

Conchetta Newton

Conchetta Newton

Project Manager, CDER, US FDA

Dr. Ranjana Pathak

Dr. Ranjana Pathak

Chief Quality Officer, Lupin

Rishikesh Jaiwant

Rishikesh Jaiwant

EVP, India Supply Chain Operations, GSK and President, PDA India Chapter

Dr. Sanjay Shetgar

Dr. Sanjay Shetgar

Vice President, NSF

Dr. Rajiv Desai

Dr. Rajiv Desai

Senior Technical Advisor, Indian Pharmaceutical Alliance (Moderator)

Nicole Knowlton

Nicole Knowlton

Regulatory Specialist, India Office, OGPS, US FDA

Dr. Annam Visala

Dr. Annam Visala

Joint Drugs Controller (India), CDSCO

Ian Jackson

Ian Jackson

Expert GMP Inspector, MHRA

Dr. Kazuji Omori

Dr. Kazuji Omori

Senior Scientist (for Inspection), PMDA

Ranga Chandrasekhar

Ranga Chandrasekhar

Joint Drugs Controller (India), CDSCO

Dr. Keshav Kumar

Dr. Keshav Kumar

Senior Advisor, Indian Pharmaceutical Alliance

Madhu Sundar M S

Madhu Sundar M S

Global Head of Quality and Pharmacovigilance, Dr. Reddy's Laboratories

Amitava Saha

Amitava Saha

CEO, PAGE Foundation

Dr. Sanjay Kumar Jain

Dr. Sanjay Kumar Jain

Chief Quality Officer, Amneal Pharmaceuticals

Helena Vilaça

Helena Vilaça

Pharmacist, Site Management Unit, EDQM

Prof. Chinmay Tumbe

Prof. Chinmay Tumbe

Associate Professor, IIM Ahmedabad

Presentation

FDA India Office: Advancing the Standard for Quality and Resilience

FDA India Office: Advancing the Standard for Quality and Resilience

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Regulatory Observation Trends: Recurring Quality-System Learnings

Regulatory Observation Trends: Recurring Quality-System Learnings

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Regulatory Observation Trends: Recurring Quality-System Learnings

Regulatory Observation Trends: Recurring Quality-System Learnings

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AI and Advanced Analytics in Quality and Manufacturing

AI and Advanced Analytics in Quality and Manufacturing

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Data Integrity and Documentation Controls: Challenges and Best Practices

Data Integrity and Documentation Controls: Challenges and Best Practices

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Quality Management Maturity (QMM) at CDER

Quality Management Maturity (QMM) at CDER

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QMM 2026: From Compliance to Predictable Performance

QMM 2026: From Compliance to Predictable Performance

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Quality Management System: Way Forward

Quality Management System: Way Forward

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Anti-Counterfeit and Supply Chain Integrity

Anti-Counterfeit and Supply Chain Integrity

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Backward Integration of APIs and Intermediates and Opportunities in CDMOs

Backward Integration of APIs and Intermediates and Opportunities in CDMOs

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Building Quality Leadership Capability

Building Quality Leadership Capability

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Sterility Assurance and Contamination Control Strategy

Sterility Assurance and Contamination Control Strategy

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The EDQM Inspection Programme: Risk-Based Inspections and Reliance

The EDQM Inspection Programme: Risk-Based Inspections and Reliance

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Indian Pharma Archives: History of Manufacturing Practices in India

Indian Pharma Archives: History of Manufacturing Practices in India

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Videos

Recording