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

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