FDA's applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed inspection means that the FDA is likely to refuse the entry of the firm's products. The webinar covers what FDA does and what you should do to prepare for an inspection, how you should manage the inspection as it takes place and what to do if you have problems. Firm's that end up with inspectional observations or a Warning Letter have a lot of work to do in a very short time frame. The webinar will provide a "quick start鈥 guide for what you should do to survive a regulatory disaster.