Sound Bites from 2016 Continuous Manufacturing Conference

"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