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Wednesday, April 11 • 1:30pm - 3:00pm
Session V - GMP Track

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V-1  Oral Poster: Quality Compliance in Global Drug Supply Chain: Examining the US Regulatory Response

Background: The US FDA enforces regulations of active pharmaceutical ingredients (APIs) manufactured abroad and used in drug products commercially sold in the U.S. However, ensuring API quality is challenging in this era of globalization where approximately 80% of API is sourced from either India or China.  This research examines findings from FDA inspection of API manufacturers located within and outside of U.S. to understand the underlying causes for non-compliance.
Methods: A comprehensive literature review was conducted to better understand the landscape of quality issues associated with APIs manufactured in U.S. and abroad. FDA warning letters from the past 5 years concerning the quality of APIs are examined to detect trends in compliance. In addition, FDA’s inspectional observations (Form FDA 483) will be obtained through FOIA requests and analyzed for content specific to API deficiencies related to quality.
Results: Findings from the literature review demonstrates that there are concerns regarding API quality from foreign manufacturers. However, little research has been conducted to understand why these quality issues exist. Investigation into this issue is challenging because companies typically do not publicly disclose API origin. The results of the ongoing analysis of the FDA warning letters and 483s will be reported. The findings from this research will provide a deeper understanding of the quality issues associated with APIs manufactured abroad, discover reasons for these quality issues, and may help inform regulators in their efforts to help protect public health.

Good Manufacturing Practices

Level of Content:

V-2  Developing a GXP Quality Manual

Abstract: TBA

Category: TBA

Level of Content: TBA

avatar for JoAnn Boyd

JoAnn Boyd

Quality Manager, Southwest Research Institute
Jo Ann Boyd, BS/MBA, is quality assurance manager for Southwest Research Institute (SwRI) Chemistry & Chemical Engineering Division (C&CED). Ms. Boyd has Lead Auditor training for ISO 9001, ISO/IEC 17025,17020, and NQA-1 requirements with extensive experience establishing quality... Read More →
avatar for Nahae Kim

Nahae Kim

Undergraduate Researcher, University of Southern California
Hannah Kim is an upcoming 3rd year undergraduate at the University of Southen California. Currently, she is researching with the USC International Center for Regulatory Science. After graduating in 2019, she hopes to pursue her PharmD.
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy, United States
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
avatar for Amelia Spinrad

Amelia Spinrad

Regulatory Knowledge Support Administrator, USC International Center For Regulatory Science
Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project... Read More →

Kim Watson

Stone Environmental, Inc
Kim has over 35 years of experience in all phases of production and laboratory procedures, quality control and quality assurance, QA management and project management in an environmental analytical laboratory in the context of EPA regulated environments (GLP, RCRA and CERCLA). She... Read More →

Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 1&2