422206 Fda's Office of Process and Facilities: Facilitating Pharmaceutical Manufacturing Quality and Innovation

Monday, November 9, 2015: 10:20 AM
Ballroom B (Salt Palace Convention Center)
Christine Moore and Rapti Madurawe, CDER/OPS/ONDQA, FDA, Silver Spring, MD

Christine Moore, Acting Director of the Office of Process and Facilities (OPF), will discuss how FDA CDER has re-organized its quality function into one super office—Office of Pharmaceutical Quality (OPQ) in mid-January 2015.  One of the landmarks is that the newly established Office of Process and Facilities (OPF) is dedicated to and fully responsible for pharmaceutical manufacturing process review and facility inspection.  The Office of Process and Facilities (OPF) ensures that quality is built into manufacturing processes and facilities over the product lifecycle.  It's vision is to be the premiere organization for integrated manufacturing process review and inspection of pharmaceutical regulation, globally.  Given the primary functions of newly established OPF and its potential huge  impact to the pharmaceutical industry and pharmaceutical engineering practice, PD2M Forum is an appropriate avenue to share these changes.

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