I believe that it depends on the job and the nature of the work since you may not need highly skilled labor for the task and employees may be expendable. sounds harsh but we see this in jobs like technicians…   Read more»

I don’t believe any information is transferable from 1 trial to another and patient data protection laws make using it without consent impossible. Technology can be used however to expedite patient selection using digital filtering based on responses similar to…   Read more»

To answer the first question, we need to look at the factors that influence R. Aside from what the others have said, there is also the companies financial situation and overall business goal. If it is a startup with lots…   Read more»

Usually change has a driving factor which comes mainly in the three, not mutually exclusive, flavors; necessity, efficiency, and profitability. In the first situation, change is unavoidable because the product at the moment is either out of spec, fails to…   Read more»

So as to not be too repetitive, having a third party review certain key documents that you may be bias towards as well as having different technicians perform testing/assembling according to the testing/assembling documents to ensure they are relatively dummy…   Read more»

The first step is identifying the type of change being requested. It can be to the BOM, Labeling, paperwork, testing procedures, storing procedures, sterilization procedures, disposing procedure, packaging, etc. Depending on the type of change requested the factors to consider…   Read more»

One thing to remember is that most if not all companies already have an “Approved Vendor List”, or AVL, for all different products and services that your company may need. The companies on the list are audits in some form…   Read more»

One thing that we need to remember is that successful project execution is not always the end goal, from a corporations standpoint, the end goal is the best way to secure financial revenue and fulfill the commitments made to make…   Read more»

If by project execution you mean the execution plan/phase of the project, then it is safe to assume that the other phases have been completed. At this point in the project progression all or a majority of background research/ investigations…   Read more»

I Agree but the first step should always be understanding the scope of the project because without that you will find new components that need procedures or additional tasks you didn’t account for. The step should also have some form…   Read more»

For the given Simulation, the glaring initial problem is the solubility of the carrier in water. while I agree with the previous statements, we need to have a plan of action before we can put them into a Gantt or…   Read more»

This depends on the financial stability of the company and how important the project you are working on is. If the project is critical and the time restraints are inflexible then going back to a previous phase would allocate resources…   Read more»

smk45 took the words out of my mouth by mentioning scope. Fully understanding the scope of the project is the first most important thing in reducing risk because unfavorable results can cause delays that can be accounted for when setting…   Read more»

You will find that the M&C is highly correlated to the a properly defined scope. Many of you have mentioned capstone, and I am sure that as you began actually building the product you realized that your understanding of the…   Read more»

While it is a terrible practice to define something with itself Project scope management is the management of the scope of the project. This is important at several phases within a project from its genesis all the way to its…   Read more»

i don’t think using the pharmaceutical industry as a comparison is a good idea since drugs like thalidomide were allowed on the market and cigarettes caused “no health issues” for such a long time. I believe that the government should…   Read more»

To address this question, quite a few factors have to be considered and I believe the answer is not as simple as a yes or no. Among the factors to consider are the location and availability of supplies that can…   Read more»

While it is easy to say make regulations elastic to do everything they intended to do without hindering innovation, practically insuring that everything is done to prevent a critical failure once on the market and deregulating as a means of…   Read more»

Since I don’t want to echo too much of what everyone said I’ll add what I think is not said. While leadership is a key role it is vague, and charisma is not really needed while it can help with…   Read more»

Any major changes, in this case material composition changes, needs to be reported to the FDA. In the event that it is a novel material or a novel use of the material, in vivo studies will have to be done…   Read more»