Does 21 CFR 11 make any statements regarding the level of training required for personnel conducting environmental monitoring?

Исследователь смотрит на пробирку с жидкостью

Yes. Part 11 specifically states “that persons who develop, maintain or ER/ES systems have the education, training, and experience to perform their assigned tasks.” Training and/or education specific to the conduct of assigned tasks should ideally be documented and stored.