Like many have said I have also been involved in root cause analysis to examine the reasoning behind something failing. In many cases, most of the root cause analysis I have done involves a lot for a...

We discussed during Innovation and Discovery some common mistakes that occur between operations and the dedicated team bringing about this change. Essentially the main takeaway of it was for companie...

I have experience with evaluating legacy products and obsoleting products. It is usually a bigger undertaking then one would think. To your point, it is very important that companies continuously ev...

I agree with this that the thought process in technical writing in industry is always "if a random person picked up this document, could they understand how it works." However, undergraduate doesn't ...

From a business standpoint, you would want to open less CAPAs. In manufacturing of medical devices most CAPAs tend to be reactive since they are usually opened after an Event, Non Conformance, SCAR (...

Ideally in manufacturing it is best practice to have spare equipment in the instance that a machine fails. Therefore, it is a simple task to bring it in and replace it. If the machine is the same ma...

I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate...

Yes, SOPs should be used in research phase. If you are looking to produce a new product to market or making changes to current products in your product line, SOPs should be strictly followed. During...

The company I currently work for generates ECOs to make specific changes to products or manufacturing processes. Our ECOs are generated in a Product Management System, we currently use Agile but ther...

In agreement that acceptance criteria needs to be re-evaluated. Before that, a deviation should be opened to address the failure of a validation and why the deviation occurred and how it will be addr...

It depends what you are looking for. The DHF would be more useful all around for people in Quality, Regulatory, Supply Chain, and even Product Development. This is because this will provide more then ...

The DHF is a living document. Logically to me it doesn't even make sense why it wouldn't be. What is the point of documenting just the original process if you are going to open a 2nd DHF if the produ...

In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to ...

Absolutely. The revisions that have taken place under the Medical Device Directives are meant to be on par or if not more stringent then the US FDA. Notified bodies showing up unannounced and greater...

I don’t believe there should be a defined limit of center or subjects because that should depend fully on what the study is. However, when choosing multi centers or shouldn’t be random centers that ch...