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: