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8th Advanced GMP Workshop 2023
Virtual October 3, 2023
Flyers
Agenda
Speakers
Presentation
Best Practices - Responding to FDA 483 Inspection Observations - Carmelo Rosa - Director Division of Drug Quality, CDER-OMQ FDA
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Cross Contamination Control Strategy with Case Study and regulatory expectations - Rahul Songire - Vice President, Central Quality, Zydus Group
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Harnessing ERP for enhanced compliance - Raghuram Janapareddy - Partner & Managing Director of India, Tenthpin
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Role of Automation and Digitization in Manufacturing and Quality - Birendra Singh - President & Global Quality Head, Mankind
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Transformation through Artificial Intelligence - Rajesh Kuppuswamy - Principal, Health Care and Life Sciences, AWS India
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Welcome and Setting the Context - Mr Sudarshan Jain, Secretary General, IPA
Inaugural Address - Mr Nilesh Gupta, Managing Director, Lupin
Keynote Address - Ms S Aparna, Secretary, Department of Pharmaceuticals
Opening Address - Current Updates on Regulatory Framework in India - Mr A K Pradhan, Joint Drugs Controller (India), CDSCO
Collaboration between IPA and PCI - Way Forward - Dr Montu Patel, President, Pharmacy Council of India
Opening Remarks - Dr Sarah McMullen, Country Director, India Office of Global Operations, US FDA
Best Practices - Responding to FDA 483 Inspection Observations - Dr Carmelo Rosa, Director Division of Drug Quality, CDER/OMQ FDA
Panel Discussion on Data Integrity within Context of Quality Culture - Shirish Belapure , Senior Technical Advisor - Quality, Regulatory & Manufacturing, IPA
Harnessing ERP for Enhanced Compliance - Mr Raghuram Janapareddy, Partner & Managing Director of India, Tenthpin
Panel Discussion on Working Towards Ensuring Adequate Drug Supply - Dr Rajiv Desai, Senior Technical Advisor - Quality and Regulatory, IPA
Case Study: Transformation through Artificial Intelligence - Dr Rajesh Kuppuswamy, Principal, Health Care and Life Sciences, AWS India Pvt Ltd
Case Study: Role of Automation & Digitization in Manufacturing and Quality - Dr Birendra Singh, President & Global Quality Head, Mankind
