This seminar provides a view of what to expect when a medical device manufacturer receives notification of an
FDA quality system inspection and suggestions for policies that can expedite inspections with more favorable
outcomes. Having foresight into what topics/questions/records are typically covered during an FDA inspection
helps a manufacturer to be better prepared for expediting the inspection and minimizing the number deficiencies
the investigator may find, i.e.: FDA483 Inspectional Observations. Depending on the device, the inspection can
cover FDA regulation sections §803, 806, 820, and 1000-1040. The seminar will also cover some FDA-483
Inspectional Observations.

Note: We believe this will be a well-attended Round Table. Be sure to reserve your seat soon. There will be a practical limit of 90 attendees. Please register early to ensure admission.