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9th Advanced GMP Workshop 2024

Virtual October 22, 2024

Flyers

Flyer

Flyer

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Agenda

Agenda

Agenda

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Speakers

Arshad H Khuroo

Arshad H Khuroo

Head, Bioavailability and Bioequivalence Sun Pharma
Dharmesh Domadia

Dharmesh Domadia

Head, Global Clinical Operations, Cliantha Research
Geena Malhotra

Geena Malhotra

Ex-Global Chief Technology Officer, Cipla & MD, Signet Excipients
Gregory Smith

Gregory Smith

Director, India Office US FDA
Guerlain Ulysse

Guerlain Ulysse

Consumer Safety Officer (Pharmaceuticals), India Office US FDA
Himanshu Gadgil

Himanshu Gadgil

Chief Executive Officer Enzene Biosciences
Kalaiselvan Ramaraju

Kalaiselvan Ramaraju

Deputy General Manager, Formulation R&D Sun Pharma Industries
Kellia Hicks

Kellia Hicks

Consumer Safety Officer India Office, USFDA
Krishna Venkatesh

Krishna Venkatesh

Head, Global Quality and Pharmacovigilance Dr Reddy's Laboratories
M E Kannan

M E Kannan

President & Head - Pharmaceutical Technology Center (PTC) Zydus Lifesciences Limited
Mahesh Ramanadham

Mahesh Ramanadham

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER USFDA
Nilesh Gupta

Nilesh Gupta

Managing Director Lupin
Prashant Sharma

Prashant Sharma

Chief Technical Officer Zydus Lifesciences
Pravin Kulkarni

Pravin Kulkarni

AVP, Halol Site Head Quality, Sterile, Sun Pharma
Rajeev Raghuvanshi

Rajeev Raghuvanshi

Drug Controller General of India Government of India
Rajendra Bandgar

Rajendra Bandgar

Head, Development Quality Assurance Dr Reddy’s Laboratories
Rajeev Sinha

Rajeev Sinha

Global Chief Manufacturing Officer Cipla
Rajendra Kumar Das

Rajendra Kumar Das

Ex-Vice President of Engineering Sun Pharma Industries and Founder, Eco-vita
Rajiv Desai

Rajiv Desai

Senior Technical Advisor Indian Pharmaceutical Alliance
Ranjana Pathak

Ranjana Pathak

Chief Quality Officer, Lupin
Ruth Moore

Ruth Moore

Consumer Safety Officer, OPMA, CDER US FDA
S M Mudda

S M Mudda

Chairman Regulatory Affairs IDMA
Samantha Atkinson

Samantha Atkinson

Executive Vice President & Principal Consultant, Lifesciences NSF
Shirish Belapure

Shirish Belapure

Senior Technical Advisor Indian Pharmaceutical Alliance
Sudarshan Jain

Sudarshan Jain

Secretary General Indian Pharmaceutical Alliance (IPA)
Vipul Doshi

Vipul Doshi

Corporate Quality & Compliance Officer, Zydus Lifesciences

Presentation

Session 6_Revised Schedule M Driving Regulatory Harmonization_S M Mudda

Session 6_Revised Schedule M Driving Regulatory Harmonization_S M Mudda

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Session 7_Achieving Operational Excellence through Continuous Manufacturing_Himanshu Gadgil

Session 7_Achieving Operational Excellence through Continuous Manufacturing_Himanshu Gadgil

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Session 7_Achieving Operational Excellence through Continuous Manufacturing_Prashant Sharma

Session 7_Achieving Operational Excellence through Continuous Manufacturing_Prashant Sharma

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Session 7_Achieving Operational Excellence through Continuous Manufacturing_Rajeev Sinha

Session 7_Achieving Operational Excellence through Continuous Manufacturing_Rajeev Sinha

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Session 8_Insights from Good Engineering Practices_Rajendra Kumar Das

Session 8_Insights from Good Engineering Practices_Rajendra Kumar Das

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Session 8_Insights from PAT in Oral Solids and APIs_R Kalaiselvan

Session 8_Insights from PAT in Oral Solids and APIs_R Kalaiselvan

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Session 10_Integrating Sustainability The Next Frontier for Pharma_Geena Malhotra

Session 10_Integrating Sustainability The Next Frontier for Pharma_Geena Malhotra

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Videos

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Session 1_Welcome and Setting the Context

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Session 1_Inaugural Remarks

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Session 1_Opening Remarks from USFDA

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Session 1_Opening Remarks

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Session 3_Strategies for Addressing FDA 483 and Warning Letters

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Session 3_Data Governance: Regulatory Expectations and Case Studies

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Session 4_Strengthening Lifecycle Management: Technical & Reguatory Considerations

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Session 5_Panel Discussion: Strengthening Quality Assurance in Clinical and BA/BE Studies

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Session 6_Revised Schedule M: Driving Regulatory Harmonization

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Session 7_Achieving Operational Excellence through Continuous Manufacturing

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Session 8_Insights from IPA Best Practices Documents

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Session 9_Panel Discussion: Advances in Cleaning Procedures to Minimize Cross Contamination

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Session 10_Integrating Sustainability: The Next Frontier for Pharma