FDA Prepares to Station Inspectors in China to Scrutinize Exports to the U.S
Featured Webinar from PharmAsia News - October 2008
Are your Chinese manufacturing facilities ready for heightened FDA inspections? What about the facilities of your outsourced Chinese suppliers? Join our exclusive Webinar on October 15 to hear from the FDA on how to prepare for inspections in China. To register or learn more, please click here.
U.S. FDA Inspections in China
Wednesday, Oct. 15, 2008 • 10 AM ET / 7AM PT • 90 minutes
Featuring:
Nicolas Buhay
Deputy Director, CDER/OC/DMPQ
U.S. Food and Drug Administration
Raymond Bonner
Partner
Sidley Austin LLP
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 helpful 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!
