I have a client who manufacturers for another company who then sells in the USA.
They have had to appoint a PCQI
In fact for a few months I was the PCQI until we could document the current Technical Manager had sufficient training.
We added the `FSMA module to the BRC audit
We have argued, successfully, that completion of the Level 3 Food Safety and Level 3 HACCP accredited courses are sufficient to meet the requirements.
There is an FDA approved specific training course but you have to find some one running it.
With regard to being audited, yes that is a real possibility
But it will be an FDA appointed auditor
There is concern that with the growth in businesses taking the FSMA module with their BRC the likelihood of an audit team coming to Europe is increasing.
A good guide is the BRC additional module, get a copy from the BRC web site and it is quite a useful guide to achieving basic FSMA compliance
But remember Preventative Controls are not always the same as HACCP