What Every FDA Regulated Company Needs to Know About its FDA District Office (FDA Compliance)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jul 18, 2012 End Date/Time: Jul 18, 2012
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Description

This webinar will cover the responsibilities of FDA District Offices and provide practical tips on what you can do to ensure your firm stands a better chance to be viewed positively by your district office and the FDA generally.

Why Should You Attend:

Any firm that expects to not have FDA regulatory issues must understand its District office and how the District Office plays such an important role. The FDA implements much of its authority to regulate food and health products for which it is responsible through its 26 district offices. The activities of district offices through inspections and other contacts with firms can well be instrumental in how the firm is regarded by the FDA, with the result that decisions and field laboratories in the Centers and Offices at FDA headquarters may be impacted by recommendations and reports of the district office. FDA views firms it regulates as either “a player” or a “non-player. By having good relations with the FDA District Office a firm will be perceived as a “player.”

FDA district offices are responsible for conducting the vast majority of establishment inspections through investigators in district offices and their sub- offices. This presentation will show how you can get to know the district office’s level of expertise in its conduct of inspections, and use this information for how your firm’s “Guide” deals with investigators. The webinar will help you understand how a compliance officer will react to a FDA 483 and Warning Letter of a firm, since this is important in any response or meeting to resolve issues following an inspection.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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