This is a good point you bring up, however I do not fully agree with the skepticism disconnect in how the industry rewards motivation. While this is definitely an issue within any industry, based off ...

For many companies, particularly the smaller ones engaged in clinical trials, outsourcing might not be so much a choice, but a necessity. As we know, clinical trials can be often very complex projects...

When identifying project priorities it is important to keep in mind some guidelines that can help balance these priorities within the project scope. Before funding a product design project, prioritie...

What motivates me is the desire to make products for those less fortunate and to know that I have made a positive difference in someone’s quality of life. An example is my current job in which I am pa...

Studies show that Americans work longer hours and have more stress-related illness than their European and Japanese counterparts. Some of this is due to stagnant wages and outdated overtime laws, but ...

In order to prepare a schedule and budget for a clinical trial there are several factors to consider. The schedule of clinical trials is basically an outline that contains all the activities that will...

QA/QC is the combination of quality assurance, the process or set of processes used to measure and assure the quality of a product, and quality control, the process of ensuring products and services m...

The Six Sigma methodology offers a structured and disciplined process for solving business problems and ensuring product/processes are within acceptable margins of error. Six Sigma uses tools designe...

Adding to previous posts, one other factor to consider are the regulations about supplier selection and management in 21 CFR 830.50. FDA scrutiny on supplier selection, criteria used, and more importa...

Design verification means confirming by objective evidence (i.e. testing) that the design outputs meet design inputs. Design Verification is one of the most important activities in the development pha...

I agree with previous posts to contact the vendor to identify the problem and a solution. However, this is not an unusual issue and typically the way that companies control these problems is by establ...

There are many factors that can affect schedule variance (SV) such change requests, issues with suppliers of materials/ components to mention a couple. These factors can impact in the timeline of a pr...

The different kinds of changes, as mentioned in previous posts, are Non-Essential Design Change (NDC), Design Change Number, and Engineering Change Order. Each one of these carry a workload in order t...

It will be prudent to include buffers in the project plan to account to the unexpected. This is a practice in two companies I have worked for developing medical devices and combination products. I alw...

Change control is another well-know concept that focuses on managing change to prevent unintended consequences. The regulations provide for change control primarily through the assigned responsibiliti...