@archishak brings up very good points, but I would also add that which option is chosen for cost estimation should also depend on the state of your or...

There is also the matter of long term effect of choosing one vs multiple vendors. If there is a need to change the DSD anyways and alter the project t...

Another strategy can be in holding stand-up meetings to keep track of every team member's task. This will ensure that critical tasks are being complet...

A good tool for ensuring that all knowledge areas are synced and properly coordinated is the Work Breakdown Structure (WBS). This tool allows the proj...

The scope is largely defined by the budget and target product release timeline. For example, the original scope for the project in the initial plannin...

Most significantly, a WBS shows 100% of the project, as in it shows every aspect, from the overall project top-level objectives, to the breakdown of t...

Most larger medical device companies have developed an 'Approval Matrix' that details out every potential type of change and document category (ex. ch...

An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity...

There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as describe...

Validation is not required when the customer need is self evident. For example, if the customer need is for a sterile device, no validation test is re...

As @shahil mentioned, setting up rules in your email to sort is a great tool for keeping your email organized. There are a few ways to do this:creatin...

@torikul Agree with all the above but especially wanted to highlight your point about running pilot studies. As a working engineer, I have seen projec...

Hi everyone! My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson. Looking forward to connecting:/p>