Integrated Manufacturing Assessment for A/NDAs
Ying Zhang, Ph.D. (FDA)
The Office of Pharmaceutical Quality (OPQ) integrates assessment, inspection, surveillance, policy, and research activities to strengthen pharmaceutical quality on a global scale. As a sub-office within OPQ, Office of Process and Facilities (OPF) assesses the drug product manufacturing process and the manufacturing facilities, leading to a single, more informed quality assessment. This presentation will describe the OPF’s responsibilities during the application review and our current review practice and will discuss the common deficiencies we have observed, with the eventual goal of facilitating the first cycle approval. Case studies will be provided.
Date and Location
Thurs Sept 19th, 2019Registration & social hour: 5:30 PM |
Meeting SponsorsTBD |
Hanover Marriott1401 Rt 10 E, Whippany, NJ 07981 |
About the speaker
As a trained chemical engineer, Dr. Ying Zhang reviews chemistry, manufacture and control (CMC) information in drug application since 2009. Her review experience covers various unit operations, scale up, control procedures and equipment used for manufacture of a variety of dosage forms, as well as facility assessment for its adequacy to support drug application approval. She is currently serving as the acting director of Division of Inspectional Assessment in Office of Process and Facilities, Office of Pharmaceutical Quality in CDER, FDA.
Registration Fees
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Registered and paid online: $50.00
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Walk-in: $65.00
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Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
Advance registration will end at 5:00 PM on WEDNESDAY SEPT 18th; after that, you must pay at the door. Note also that if you choose the "Register and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.
Note: in the event a meeting needs to be cancelled due to weather or other conditions, NJPhAST will do its best to notify all registrants as soon as possible; however, we ask that you exercise individual judgement if you do not hear directly from NJPhAST.