Rania,
Thank you for the information.
Let me distinguish between requirements and good practices.
In the material you cited I don't see a requirement to train internal auditors on the MDR.
Consider three phases in MDR implementation: writing procedures that comply with the MDR, implementing the procedures, and checking the implementation (using internal audits).
How did you train the people who wrote the procedures? Did they go to an MDR course? The point I'm making is training doesn't apply to auditors only.
On another issue, you need to be clear about the role of the auditor. If the auditor is checking procedures against the MDR requirements, then that duplicates the work done in document control. I recommend that auditors check that the implementation of properly issued procedures and not procedure conformance to some external requirement.
It is certainly good practice for people involved in MDR implementation to have received training. It is complicated and there a lot of pitfalls.
For training, there are two options. Send people to a public course or have the training brought in house. When I doing this kind work I did a lot of public courses as well as company courses. In those case I would tailor the training to the company.
Public course usually charge by the head. For in-house courses, I would charge for the training session regardless of the number of people in the room. This is a cost effective way to get a lot of people trained and to hear the same message.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 16-Feb-2022 09:12
From: Rania deLeon
Subject: MDR Internal Audit Training Certificate
Hi Dan,
We heard it off the cuff by an external auditor and also saw it in the MDR readiness checklists provided to us. Here is what was cited on those checklists.
MDR Readiness Checklist;
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Rania deLeon
QA & RA Manager
Morton PA
United States
Original Message:
Sent: 15-Feb-2022 16:04
From: Dan O'Leary
Subject: MDR Internal Audit Training Certificate
Cn you state the source of the requirement for internal auditor training?
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 15-Feb-2022 15:30
From: Rania deLeon
Subject: MDR Internal Audit Training Certificate
Hello,
We saw that for MDR there is a requirement for the internal auditors should be trained to perform internal audits to the MDR. All of the ones we found are ridiculously expensive or don't provide a certificate at the end of training. Has anyone found a reasonably priced training program that ideally provides a certificate upon completion?
Thank in advance for the input!
Rania
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Rania deLeon
QA & RA Manager
Morton PA
United States
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