Self Training

GOOD MANUFACTURING PRACTICE (cGMP)
1

Would anyone be able to tell me or direct me to the FDA’s stance of self-training if they have one?

Also, from your experiences how did you implement this into you’re training programs.

Seal

2

The regulations only require that employees are competent to do their job. One means to support this claim is training. Self-training is ok as long as there is a record. The Quality Audit should support that training is effective. So if you have a record of the training and your audits show that personnel are able to correctly perform their jobs (esp. from a quality perspective), you should be ok.

Regarding how this is done in the training program, we have documented evidence that an employee completed the training. We indicate on the form that it was self training.

3

As a Health Canada Inspector…I would not accept self training…when it comes to operational procedures.

Eg. Operating equipment, etc. How would the person be assessed?

If the person underwent self training, and then was given a thorough and all-encompassing theroetical and practical exam, I would probably accept that.

4

Dear

Canada sir

i am QA In API Unit , Some times we are receiving core revised documents from our corporate QA, but they are not providing training to us , but they will share through phone, changes from previous to revised document, but we are conducting Training to our plant people with document evidence, but auditors asking my training record on particular training program, how to answer to auditor , solution please

Regards
Murali

5

any one please explain , at the time scale up, up to what % , validation is not required, please explain , and also please guide, what guideline supporting

6

Scale up is generally 10X, x is the validation batch size.

7

Hi muralikrg,

Sorry I haven’t been home much, lots of traveling so I didn’t check the board recently.

I understand your question.

I might have been a little bit rash with my self training answer. I would need to know more. It is possible, that a person be “grandfathered” in, because they have been around so long (possibly before a training program existed). In that case, that person would be considered trained and an expert.

Now in terms of head office telling you of changes…that is acceptable…IF:

  1. A senior individual (Manager, supervisor, etc) is told of the changes by QA. Sounds like revisions to an SOP. This is considered okay.
  2. Since that senior individuals are now trained, it is now acceptable for the senior individuals who are trained and signed off by QA that they received training, that they then train the production people.

QA should be providing training evidence, even though it’s over a telephone. A training record stating Employee X was training on SOP X on Date X.

Does this help?

8

Thank you sir