Workshops on FDA medical device inspections outside US

11 April 2008

FDANews, a provider of regulatory, legislative and business news and information related to the US Food and Drug Administration, is holding two workshops in Europe to help medical device companies prepare for an FDA inspection.

The US Government Accountability Office and high-profile members of Congress have made foreign inspections by the FDA a top priority, following a report that the agency has not been inspecting foreign sites as it should have been over the last several years. This means foreign inspections of medical device companies will increase.

The workshops will be on June 19-20 in Hamburg and on June 24-25 in Dublin. Attendees will gain insight on how the FDA operates (from the inside) and secrets of what effective companies have done to overcome results of a poor audit.

The two-day workshops will cover:

  • the top five most common issues cited in FDA warning letters;
  • what three things happen when a warning letter arrives, and what the direct and hidden impact on business operations may be;
  • why foreign companies are at a disadvantage during FDA inspections;
  • how the FDA decides to inspect a foreign company, select the investigator and prepare for the inspection;
  • the ten most common FDA 483 observations of foreign companies inspected by the FDA;
  • six steps to ensure success and prevent a warning letter; and
  • what to do when things go wrong: strategies for reporting MDRs, corrections and removals, and recalls to FDA.

More details of the workshops can be found at:

To top