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U.S.
FDA Inspections in China |
Wednesday, Oct. 15, 2008 • 10 AM ET / 7AM PT • 90 minutes
About the event • Key topics
• Who should attend • Speakers
• Benefits • Register
Featuring
Nicolas
Buhay
Deputy
Director, CDER/OC/DMPQ
U.S. Food and Drug Administration
Raymond
Bonner
Partner
Sidley Austin LLP
Audio recording only: $499
In 2008, foreign manufacturing sites will exceed domestic ones for U.S. FDA-regulated products for the first time. China has more establishments manufacturing drugs offered for entry into the U.S. than any other country. However, only 11 percent, or 80 of 714 drug establishments in China, were inspected by FDA during fiscal years 2002–2007. From the heparin debacle to the recent infant formula safety scare, consumers’ concerns are increasing over China-produced food, toys and pharmaceutical ingredients.
In response, FDA will station inspectors in three Chinese cities to scrutinize exports to the U.S. Up to 15 inspectors will be assigned to Beijing, Shanghai and Guangzhou starting in October, according to U.S. Secretary of Health and Human Services Michael Leavitt.
Are your Chinese manufacturing facilities ready for stepped up FDA inspections? What about the facilities of your outsourced Chinese suppliers? Sponsors are responsible for the violations of their suppliers. Learn what you must do today to prepare for U.S. FDA inspections in China.
Join us for a thought-provoking analysis of this changing paradigm. Grab your team, a phone and a computer with Web access (that last one's optional). No travel required.
Walk away with guidance in the following areas:
- What to expect from FDA’s new offices in China
- Which systems and regulatory issues FDA inspectors will focus on in China
- How to prepare Chinese manufacturing sites for rigorous inspections
- How to audit Chinese material suppliers to ensure compliance with quality and regulatory requirements
- How to ensure the best communication between your staff in China and FDA inspectors
- How to effectively communicate with FDA and management concerning resolution of observations and inspection issues
- How to address warning letters and import holds arising out of China-based inspections
... and much more!
This webinar is aimed at executives in pharmaceutical, biotechnology and medical device companies, including:
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Senior management
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Corporate counsel
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Regulatory affairs officials
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Compliance officers
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Internal auditors
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Manufacturing managers in China
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Nicolas
Buhay Nick Buhay is the Deputy Director in CDER's Division of Manufacturing and Product Quality. He has worked in FDA for 37 years. Mr. Buhay’s career began as an investigator in the New York District Office, where he made inspections of factories manufacturing products regulated by the FDA. He was promoted to a program specialist position in the New York Regional Office where he made management studies of field operations and evaluated the program operations of the six subordinate district offices in the region. Mr. Buhay has also held a supervisory investigator position in San Juan District Office, where he supervised a group of 10 investigators in the evaluation of the manufacturing operations in factories, specializing in the evaluation of drug and medical device industries. At DMPQ, as a staff compliance officer, Mr. Buhay has evaluated field office recommendations for regulatory and legal actions based on deviations from current good manufacturing practice requirements and has participated in policy interpretation and development for current good manufacturing practice. During his time with DMPQ, he was detailed for four years as a special agent supporting investigations of felony violations of the Act by the US Attorney/District of Maryland. He has been the Deputy Director of the Division for 11 years. |
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Raymond
Bonner Raymond A. Bonner served as an Assistant U.S. Attorney in the District of Maryland for six years, where he prosecuted major pharmaceutical fraud and GMP cases, and litigated other FDA-related cases. He concentrates his practice on FDA and healthcare-related enforcement matters. Throughout his tenure as a prosecutor, Mr. Bonner counseled FDA and its Special Prosecution Staff investigating the health care industry and developed extensive FFDCA experience. He has substantial experience with regulatory reporting and submission requirements, good manufacturing and laboratory practices, and marketing and labeling requirements and also counsels industry manufacturers on Industrial Espionage matters. Mr. Bonner is the recipient of FDA's Harvey W. Wiley Medal and Commissioner's Special Citation. He received his J.D. from New York University School of Law and a B.A., summa cum laude, from the University of Maryland, and clerked for the Honorable Paul H. Roney of the Eleventh Circuit Court of Appeals. |
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One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
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One (1) password to a website on which you'll be taken through the presenter's slides as they speak to them.
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An interactive Q&A round with speakers: Type your questions on the website during the presentation, for the speakers to address afterward.
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Online access to the audio and slides of the entire event if you can't attend the webinar live, and still want to hear the content.
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The insight you've come to expect and respect from FDC Reports and our guest speakers.
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Convenience – and lower cost.Your entire team can listen in one room. No travel required!
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A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
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Interactivity.You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
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Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry — the recording is available for purchase at any time!
Register for the live webinar, the live webinar + CD recording or CD recording only!
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Register online: Click here for the live webinar
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Register online: Click here for the live webinar PLUS recording
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Buy the recording: Click here for just the recorded webinar
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