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a Joint India and Singapore Chapter webinar.
Agenda
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50
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14
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14
00
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14
05
Welcome remarks
Bruce Loxley•Shirish Belapure14
05
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14
50
Product Lifecycle Strategy and Management for Next Generation Manufacturing
Linzy Lin Approaches to minimize upfront investment and maximize flexibility
Facility design, procedural controls and closed processing
Lessons learnt from commercial implementation of Next Generation Manufacturing through case studies
14
50
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15
35
15
35
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16
10
Welcome remarks
Speakers
Bruce Loxley
Senior Manager - Audit I&TPO at GlaxoSmithKline VaccinesBruce is the current President of the PDA Singapore Chapter
Shirish Belapure
Managing Director of Zydus Hospira Oncology Pvt. Ltd.Shiriz is the President of the PDA India Chapter
Product Lifecycle Strategy and Management for Next Generation Manufacturing
Approaches to minimize upfront investment and maximize flexibility Facility design, procedural controls and closed processing Lessons learnt from commercial implementation of Next Generation Manufacturing through case studies
Speakers
Linzy Lin
Senior Manufacturing Manager at Amgen Biotechnology Singapore Pte. Ltd.Linzy Lin is the Senior Manufacturing Manager leading the ASM1 Manufacturing Execution team. Her role encompasses providing leadership and oversight to manufacturing operations, ensuring reliable supply of quality drug substance in a safe and compliant manner.
Linzy has more than 10 years of experience working in various Biopharmaceutical/ Medical Devices manufacturing companies, where she held positions of increasing responsibility, providing support for daily operations, leading continuous improvement projects, product transfers and validation activities. Prior to Amgen, Linzy previously lectured on Biopharmaceutical Technology in Temasek Polytechnic, worked in Merck Sharp & Dhome, Edwards Life Sciences, Roche Singapore Technical Operations and GlaxoSmithKline (UK).
Linzy holds a Bachelor of Chemical & Biomolecular Engineering from Nanyang Technological University of Singapore.
Developmental perspective and challenges for Combination Products
Speakers
Sumitra Pillai
Vice President- Head R&D at Slayback Pharma India LLPDr.Sumitra Pillai is a pharmaceutical professional with around two decades of industrial experience. Currently she is Vice President- Head R & D at Slayback Pharma, India. Dr. Pillai has also worked with other Indian Pharmaceutical giants such as Aurobindo Pharma, Zydus Cadila Healthcare Ltd Intas Pharma and Dr. Reddys Laboratories. Her experience includes development, scale-up and successful approval of Parenteral and Ophthalmic products globally with core focus on leading geographies like North America and Europe. Dr. Pillai holds a doctorate in Pharmaceutical Sciences.
EU Medical Device Regulation – What is New and First Lesson Learnt
Speakers
Mike Wallenstein
Global Head MDR Implementation & DD&C Compliance at Novartis Pharmaceuticals AGMike is managing all activities related to the European Medical Device Regulation (EU MDR) implementation for Medical Devices & Combination Products at Novartis globally.
Mike has more than 20 years of experience in EMEA & FDA Regulations, Aseptic Processing, API/ Drug Product Manufacturing, Medical Devices, Combination Products, Providing global compliance oversight for all sites of Alcon, Novartis Pharma, and Sandoz handling Devices & Combination Products. Global certified Lead Auditor for Medical Devices, Drugs, and Combination Products.
Speakers
Mike Wallenstein
Global Head MDR Implementation & DD&C Compliance at Novartis Pharmaceuticals AG
More Information
Mike
Wallenstein
Global Head MDR Implementation & DD&C Compliance at Novartis Pharmaceuticals AG
Mike is managing all activities related to the European Medical Device Regulation (EU MDR) implementation for Medical Devices & Combination Products at Novartis globally.
Mike has more than 20 years of experience in EMEA & FDA Regulations, Aseptic Processing, API/ Drug Product Manufacturing, Medical Devices, Combination Products, Providing global compliance oversight for all sites of Alcon, Novartis Pharma, and Sandoz handling Devices & Combination Products. Global certified Lead Auditor for Medical Devices, Drugs, and Combination Products.
Bruce Loxley
Senior Manager - Audit I&TPO at GlaxoSmithKline Vaccines
Bruce is the current President of the PDA Singapore Chapter
Linzy Lin
Senior Manufacturing Manager at Amgen Biotechnology Singapore Pte. Ltd.
Linzy Lin is the Senior Manufacturing Manager leading the ASM1 Manufacturing Execution team. Her role encompasses providing leadership and oversight to manufacturing operations, ensuring reliable supply of quality drug substance in a safe and compliant manner.
Linzy has more than 10 years of experience working in various Biopharmaceutical/ Medical Devices manufacturing companies, where she held positions of increasing responsibility, providing support for daily operations, leading continuous improvement projects, product transfers and validation activities. Prior to Amgen, Linzy previously lectured on Biopharmaceutical Technology in Temasek Polytechnic, worked in Merck Sharp & Dhome, Edwards Life Sciences, Roche Singapore Technical Operations and GlaxoSmithKline (UK).
Linzy holds a Bachelor of Chemical & Biomolecular Engineering from Nanyang Technological University of Singapore.
Sumitra
Pillai
Vice President- Head R&D at Slayback Pharma India LLP
Dr.Sumitra Pillai is a pharmaceutical professional with around two decades of industrial experience. Currently she is Vice President- Head R & D at Slayback Pharma, India. Dr. Pillai has also worked with other Indian Pharmaceutical giants such as Aurobindo Pharma, Zydus Cadila Healthcare Ltd Intas Pharma and Dr. Reddys Laboratories. Her experience includes development, scale-up and successful approval of Parenteral and Ophthalmic products globally with core focus on leading geographies like North America and Europe. Dr. Pillai holds a doctorate in Pharmaceutical Sciences.
Shirish
Belapure
Managing Director of Zydus Hospira Oncology Pvt. Ltd.
Shiriz is the President of the PDA India Chapter
