Is there a requirement that training records be signed by the individual to indicate that they attended the training? I can’t find anything specifically in the regulations that requires a signature, attendance log may or may not be signed as a matter of course, but I don’t see a specific requirement. There’s there logical or common sense approach “of course a record must be signed”, but I don’t find that argument to be logical or of common sense.
Thanks for your thoughts
What you’re doing is using training records to show compliance to 820.20(b)(2) and 820.25. Thus, the training records become quality records and you’d be expected to show that they have a certain level of integrity; i.e., the HR manager didn’t just dump a bunch of training records in the files to cover themselves. Obviously the best way is to have the trainee sign something indicating they participated in the training. If you define a different way that maintains the integrity of the record and you can defend it, you might raise some eyebrows but you shouldn’t be prevented from doing so.
Many times, companies have policy that dictates trainees sign something so ensure that whatever you do, you comply with internal policies.
Just to play it out a little more, the trend (with auditors / inspectors) is that just having a training record is not sufficient to show competence. A method to address this is to have the trainer give the trainee some kind of competence assessment at the end of the training. This could be through a quiz, an exercise, or interview. To ensure integrity of the assertion of competence, the trainer (or tester) should also sign attesting to the competence achieved.
[COLOR="#000000"]WHO guidance:
6.3.2 Employee-training record
This is a record of the history of the training and results obtained for each employee,which will detail the kind of training received, the date, and the names and signatures of the trainer and the trainee.
Managers and supervisors need to be trained in their responsibilities under GMPs and good laboratory practice (GLPs) for non-clinical studies. This includes knowing what their signature means from a legal perspective. High-level managers must understand the consequences of negligence, for example. If a serious quality problem occurs or if a serious problem exists in clinical trials, and it is later discovered that a manager was negligent in following the law or in directing others to follow the law, then he or she can be sent to prison, or the facility or the study can be shut down .[/color]