Hello,

I work in a pharmaceutical company that purchased a medical device. My job is to write all of the procedures that we will need to comply with the medical device regulations (both CFR 820 and ISO 13485). - Does anyone have any experience with the training requirements in a situation like this?

We already conduct scheduled GMP training for all employees in order to comply with CFR 211 for pharmaceuticals. However, when I made the suggestion that we should also do some training on the regulations for devices, my boss (Director of QA) became somewhat agitated and stated that the GMP training was sufficient. His opinion is that the regulations for 820 are "redundant" and "common sense". - So now I'm wondering how auditors will respond to our situation. Any ideas?

Thanks,
Jim

It would seem that naturally you would want any such training to be organized on a comparative basis, identifying the areas of equivalence and the differences, with a training focus on the latter.

If organized on that basis, it would seem that the "redundant" comment would become inapplicable.

As to "common sense", well, sure...no one ever needs training because it's all common sense, right?

Hello,

I work in a pharmaceutical company that purchased a medical device. My job is to write all of the procedures that we will need to comply with the medical device regulations (both CFR 820 and ISO 13485). - Does anyone have any experience with the training requirements in a situation like this?

We already conduct scheduled GMP training for all employees in order to comply with CFR 211 for pharmaceuticals. However, when I made the suggestion that we should also do some training on the regulations for devices, my boss (Director of QA) became somewhat agitated and stated that the GMP training was sufficient. His opinion is that the regulations for 820 are "redundant" and "common sense". - So now I'm wondering how auditors will respond to our situation. Any ideas?

Thanks,
Jim


Hi Jim and welcome to the Cove! :bigwave:

Is your company currently registered to ISO 13485, or are there plans to become registered? If so, then it would be a good idea to go ahead and put together some in-house training or budget for external training, because there is a difference in the requirements for pharma and medical devices. And if the same employees will be working in both sides of the business (pharma and devices), they will need to be adequately trained and proven competent in the areas where they'll be working.

Competency will be an important part of an audit; how the competency is determined may include training and/or evaluation, observation, etc., which will need to be done and documented appropriately.

I hope this helps. I'm sure other Covers will jump in with additional information, as well.

Hello,

I work in a pharmaceutical company that purchased a medical device. My job is to write all of the procedures that we will need to comply with the medical device regulations (both CFR 820 and ISO 13485). - Does anyone have any experience with the training requirements in a situation like this?

We already conduct scheduled GMP training for all employees in order to comply with CFR 211 for pharmaceuticals. However, when I made the suggestion that we should also do some training on the regulations for devices, my boss (Director of QA) became somewhat agitated and stated that the GMP training was sufficient. His opinion is that the regulations for 820 are "redundant" and "common sense". - So now I'm wondering how auditors will respond to our situation. Any ideas?

Thanks,
Jim

Your boss needs to rethink on what he commented on 21 CFR Part 820 and ISO 13485. These may not as stringent as 21 CFR Part 210 and 211, but are quite exhaustive in its own aspects and are not "common sense".

If you show CFR 210 and 211 training records to Medical device auditors, it would be defintely a mismatch and probably a NC.

For training information I would suggest going to www.aami.org.

Last fall I attended training given by AAMI for 21 CFR Part 820. The information was very well presented, representatives from the FDA were also present to give their view of the regulations.

From the semiar presentation/notes you could develop your own interal training

Phil

Hi All,

Thanks for the feedback. It seems that my boss is reconsidering his position somewhat. We have his okay to conduct some training on the differences between 211 and 820. He only wants use to train a very limited number of people, but I'll take what I can get! - Hopefully it helps resolve some of the issues I have been having. It's difficult to get SOPs approved when none of the approvers are trained & everyone has a different impression of what is required. :bonk:

As far as ISO goes, that's a whole other problem. We aren't ISO certified now, but definitely need to be for this product. I think that the plan is to get ISO certified during the first half of next year. However, I think that we should begin the ISO training as soon as possible, so that we can begin the transition.

Does anyone have a comparison of CFR 211 to CFR 820 available?

Thanks,
Jim

Jim,

I dont understand your question. Your company "purchased" a medical device . What does this mean ?

a. This was a legally marketed medical device with 510K that you will be marketing and distributing ? Will this device be manufactured at its prior facility?.

b. This was a legally marketed medical device with 510K that you will be manufacturing. In this case, did you acquire existing Device Master Record, Design History Files; etc. etc. How about their quality manual.

Each option has their own set of follow ups. Obviously option b is a huge thing. I would suggest getting a competent consultant to help you with this. In option "b" you will have to essentially recreate the wheel; re-do the validations etc. etc.

Hi Dash,

Our situation is option 'b'. We have purchased a marketed product that we plan on manufacturing in house. The original owner contracted out all the work. They manufacturing was performed in two parts at two different facilities. One part will continue to be manufactured by the vendor, but the other part we plan on manufacturing on-site.

Like you said, we need to reinvent the wheel. My company had a consultant come here just before I was hired. The consultant did an assessment, but the problem is that my boss doesn't agree with what the consultant said. - Today I was trying to convince them to have a different consultant come and do an assessment. That way well either confirm the original consultant's findings or be able to justify doing something different.

Thanks,
Jim

Well, I guess things out in the long run. The VP of Quality has gotten involved in the situation & is pushing for us to have a consultant come in and perform training on the medical device regulations. My boss isn't thrilled about the idea, but at least I'll feel more comfortable. I guess things work out for the best sometimes.

In some instances, the core/ base areas (such as quality control, calibration, complaint handling, training) are performed in the same way. However, there are differences, such as pertaining to purchaing controls, design controls, and process validation.

Additionally, it becomes quite clear when an FDA investigator or internal auditor with pharma training audits the medical device area (and visa-versa).

Therefore, people and managers performing 21 CFR 803, 806, 820, and 821 operations, are to be trained in these areas. If problems are found in the areas of internal audits, design control, CAPA, and process validation (for example) and there are no training records to show that personnel were trained in these CFR areas + the quality policy, this just adds more evidence of systematic non-compliance problems.