Thank you for the info Marshall.
To me observing it is unclear and I would expect there to be a formal way to assess competency given this is a course required by legislation.
Maybe it will become more apparent in the future.
Ah, but the course is NOT required...
In typical FDA fashion, they noted that a "qualified individual" is someone with the "training, education, experience, or combination of the three" (not a direct quote, but pretty close to it). When they were told during the question period that this was extremely vague, they said essentially "It's like the definition of pornography, I'll know it when I see it."
Then, they FINALLY came out with a training and testing plan that has been "approved".
In other words, "we won't tell you what levels of training, experience, and education makes for a 'qualified individual', but if you take and pass this 2.5-3 day course with a street price of $800-1200 (so I have seen thus far), then you can PROVE you are a "qualified individual" because you have passed our approved test".
While it is not a mandate, it's pretty damn close to one. I don't know of any companies that aren't sending at least one if not 2 people to a seminar (and these are small to mid sized companies) so they can get officially "qualified".
It's a license to print money for the consultants, trainers, and university outreach programs.