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he FDA, under immense pressure from Congress and the public to increase oversight of Chinese firms that manufacture products for drug- and devicemakers, established an office in Beijing last year. Since making the announcement, the FDA has provided little information about what the agency staff is doing there.
Who works in the office? What are the staff’s responsibilities? How are they organized? Are they finding and correcting violations? Is it now more expensive to contract with Chinese companies? Is the FDA slowing down imports?
Direct from Beijing — Get the answers to these and many more questions …
Direct from Beijing (note our early time frame), in this 90-minute webinar, Gordon Schatz will give you the benefit of his interactions with the FDA staff in Beijing as he explains what they do, what they inspect and what they are finding. In addition, he’ll explain what it means now to outsource to, or import from, China. The law firm Reed Smith has detailed Gordon to China for a year to work in Beijing. Working closely with FDA staff and China-based contract suppliers and manufacturers, no one is closer to the action than Gordon.
If you ever wanted a first-hand account of what’s happening in China, you must register now for this exciting webinar. Sign up your entire team to listen in and discover:
* The mission and organizational structure of the FDA’s China office — including who, what, where, when and how the office operates
* What the responsibilities of the staff are (inspecting facilities or products ready for export?)
* Analysis of the regulatory actions and sanctions they have taken or violations they have found to date
* Drug and device firms’ experiences with the new system
* Whether the FDA’s actions are making outsourcing to China less cost-effective
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