Change Control Training - Change Control for Medical Devices

[Philipp]

Hi,

I'm new here in the forum and have a question related to training. Does anyone know a training on change control for medical devices, you could recommend? I am looking preferably for a training course in Europe, but in the U.S. is also possible.

Thank you.
Philipp

 

[Wes Bucey]

Re: Change control training?

Hi,

I'm new here in the forum and have a question related to training. Does anyone know a training on change control for medical devices, you could recommend? I am looking preferably for a training course in Europe, but in the U.S. is also possible.

Thank you.
Philipp

I'm not quite clear on your situation. "Change control" is an an ambiguous term in that it can apply to something like:

1. the orderly processing of a design change to a device
   or, in a broader sense, to
2. the orderly processing of a change to the operation of an entire organization.

Sometimes folks are a little bewildered by the need for a systematic process of

1. (recognizing need for change) wanting a change in design or process (reasons can be myriad, ranging from cost to more effective product for end user.)
2. (authoring) assigning an individual to draft the change, making sure ALL the allied processes will continue to match, sometimes making it necessary to change them, too.
3. (approval) having other individuals check the changes to assure they are workable and match all other processes
4. (issue) issuing the change, simultaneously withdrawing the previous version
5. (notice & implementation) notifying all interested parties of the change and confirming they are aware and will implement the change
6. (evaluation) evaluating the change down the road to assure it works as intended

Change for medical devices adds a special step in the approval process - making sure the change is notified to regulators and their approval added before issuing and implementing the change.

There are countless books, consultants, and courses (seminar type) which address the philosophy and/or management of change. Tell us more about your personal situation so we can narrow the focus of our answers.

 

[Philipp]

Re: Change control training?

Hello,

thanks for the reply. I'm just looking for training, seminars or conferences. I've already read a lot of literature and I have also spoken with our consultants.
All courses, which I’ve found in the internet, are either just for the pharmaceutical industry, or change control is only treated as a sub-theme (Validation, Design Control, CAPA, document control).
I am looking for a training course in which the main theme is Change Control.

Regards
Philipp

 

[Wes Bucey]

I repeat - for a device? or for an entire organization's processes?

 

[Philipp]

Device. Class III vascular implants.

 

[Wes Bucey]

Hi,

I'm new here in the forum and have a question related to training. Does anyone know a training on change control for medical devices, you could recommend? I am looking preferably for a training course in Europe, but in the U.S. is also possible.

Thank you.
Philipp

I'm not quite clear on your situation. "Change control" is an an ambiguous term in that it can apply to something like:

1. the orderly processing of a design change to a device
   or, in a broader sense, to
2. the orderly processing of a change to the operation of an entire organization.

Sometimes folks are a little bewildered by the need for a systematic process of

1. (recognizing need for change) wanting a change in design or process (reasons can be myriad, ranging from cost to more effective product for end user.)
2. (authoring) assigning an individual to draft the change, making sure ALL the allied processes will continue to match, sometimes making it necessary to change them, too.
3. (approval) having other individuals check the changes to assure they are workable and match all other processes
4. (issue) issuing the change, simultaneously withdrawing the previous version
5. (notice & implementation) notifying all interested parties of the change and confirming they are aware and will implement the change
6. (evaluation) evaluating the change down the road to assure it works as intended

Change for medical devices adds a special step in the approval process - making sure the change is notified to regulators and their approval added before issuing and implementing the change.

There are countless books, consultants, and courses (seminar type) which address the philosophy and/or management of change. Tell us more about your personal situation so we can narrow the focus of our answers.

Hello,

thanks for the reply. I'm just looking for training, seminars or conferences. I've already read a lot of literature and I have also spoken with our consultants.
All courses, which I’ve found in the internet, are either just for the pharmaceutical industry, or change control is only treated as a sub-theme (Validation, Design Control, CAPA, document control).
I am looking for a training course in which the main theme is Change Control.

Regards
Philipp

Device. Class III vascular implants.

Frankly, I think "change control" is so basic when applied to a product design that very little or no training is required. Some years back, I posted a sample "Engineering Change Order" format which, if followed, is almost fool proof. In any medical device, pharmaceutical, aircraft, aerospace, and any other industries with government regulations, you would simply add a section related to observing such regulatory requirements.

When I was in aerospace, dealing with FAA on a weekly basis, we had such a section. Although my firm was FDA registered, we only made components to a customer's design and, hence, did not deal with design change except as a recipient of a fait accompli from a customer.

Training to use such a form might merely be explaining the impact on the organization ($$$) for not following the format systematically and consistently.

 

[Philipp]

Hi,
maybe I have not made ​​myself clear enough. We do not need a new change control process or a new ECO form. Our ECO form is completely "fool - proof"(self explanatory).
I'm just looking for a training course for myself.
I want to get a few new food for thought. (for example, working with decision trees, etc.)

Thanks anyway
Regrads
Philipp