Six Sigma Quality & Consortia - 2018 Continuous Manufacturing Workshop Recap
Six Sigma is an approach for pharmaceutical manufacturing quality that can help to eliminate drug shortages and recalls and improve performance issues. Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, FDA Center for Drug Evaluation and Research (CDER), provided an overview of key factors around the move to Six Sigma quality in pharma manufacturing in his presentation “The Future of Pharmaceutical Quality” at the 2018 ISPE Continuous Manufacturing Workshop opening plenary session. The Workshop took place in Arlington, Virginia, on 6–7 June. The sidebar “How Global Consortia Are Advancing Continuous Manufacturing” features highlights from another presentation during the opening plenary session.