FDA inspections - helpful tips from practice

The FDA continues to tighten the reins. The American findings and warning letters continue to increase. In addition to the well-known challenges such as CAPA and Complaints, the topics of computer system validation and documentation are increasingly coming to the fore. After many years of only selective testing, the authority decided in 2010 to audit these areas much more strongly. As a consequence, this means that it will no longer be possible to deliver products to the USA in the medium to long term without implementing the legal requirements!
In this context, have you ever asked yourself how an FDA audit actually works in practice, or are you even about to have an FDA inspection?

In the 30-minute recording, Marc Holfelder, Managing Director of LA2 GmbH, talks about his experiences over the past 15 years with FDA inspections.