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Sound Bites from 2016 Continuous Manufacturing Conference

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"Many of the benefits of continuous manufacturing increase when you go end-to-end" ~ Richard Braatz, PhD, Edwin R. Gilliland Professor of Chemical Engineering, Novartis-MIT Center for Continuous Manufacturing


"We believe existing guidance & regulations are adaptable to continuous manufacturing" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ


"3 key advantages to a CM business case: development, tech transfer &  commercial production" ~ Lawrence De Belder, Senior Principal Engineer, Johnson & Johnson, Belgium


"FDA supports continuous processing for pharmaceutical manufacturing" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ


"Continuous manufacturing is one of the steps towards reliable drug quality, benefits patients and industry" ~ Rapti Madurawe, PhD, Division Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ, Conference Co-Chair


"While there are no guidelines specific to continuous manufacturing in Europe, continuous manufacturing fits well with existing EMA guidelines" ~ Dolores Hernan Perez de la Ossa, PhD, Quality Specialist, Regulatory/Human Medicines/Scientific Advice and Protocol Assistance, EMA, United Kingdom


"Pre-approval inspection decision made based on product, process, and facility risk" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ


"Data integrity important even in a high-tech environment" ~ Speaker at 2016 Continuous Manufacturing Conference


"Process for reviewing batch records will be compressed for continuous manufacturing" ~ Speaker at 2016 Continuous Manufacturing Conference


"Traceability is important, especially for different segments of a production run" ~ David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ


"Early dialogue with FDA, EMA is recommended" ~ Speaker at 2016 Continuous Manufacturing Conference


ISPE 2016 Continuous Manufacturing Conference Regulatory Panel    2016 ISPE Continuous Manufacturing Conference Attendee  

2016 ISPE Continuous Manufacturing Conference Speaker    2016 ISPE Continuous Manufacturing Conference Speaker