This course reviews the necessary preparations for a successful QSR inspection with the US FDA.
For US companies, effective preparation can lead to shorter inspections and fewer disruptions in company operations. Ineffective preparation can result in multiple quality system regulation (QSR) problems.
For non-US companies, effective preparation can lead to fewer nonconformities or none at all. Ineffective preparation can lead to a US FDA warning letter or even auto-detention (when a product is stopped at the US entry port and is not allowed to be shipped to its destination).
Therefore, it is more important now than ever for medical device manufacturers to effectively prepare for US FDA medical device inspections.
To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx