From how I am understanding the question, I believe that it is never good to miss a major milestone of a project. Having said this, the missed milestone is definitely a wakeup call to everyone in the project team that…   Read more»

In my time as a research assistant at a drug discovery & development laboratory, Work Breakdown Structure (WBS) was utilized to effectively break up the different tasks required to publish a new drug compound. The task breakdown included R&D, Drug…   Read more»

One particular project I had worked on at a drug discovery & development laboratory ran into the issue of missing a milestone. In this situation, the Gantt chart had planned for 4 researchers to work on a complete the initial…   Read more»

In my time as a research assistant at a drug discovery & development laboratory, I ran into a particular issue that I believe had the potential to affect the critical path of the project I was working on. The drug…   Read more»

In regards to the original question of “does a budget cut affect the cost estimation of a project”, I believe it does. However, I would like to add to the conversation that the timing of the budget cut within the…   Read more»

There are several severe negative results that can occur within a company that results from an underestimation of cost of a project or a unforeseen budget cut. As mentioned above, layoffs, wasted time and resources, and overall employee moral are…   Read more»

In my work experience at Bristol-Myers Squibb, I noticed key environmental factors that influenced how the company functioned. Their organizational culture/ structure were very well defined into specialized departments (silos) that preformed primarily project based tasks. In addition, the Symyx…   Read more»

If I was a project manager and putting together a successful project team, I would be mainly concerned with 3 key skills: area of expertise, teamwork compatibility, and their ability to successfully communicate their ideas to the rest of the…   Read more»

I tend to agree with bb254 and Chaudhry that as marketed by its company, Fitbit PurePulse tracker is pitched as a “general wellness use and present a low risk to the safety of the user.” As long as the Fitbit…   Read more»

I also agree with bb252 and Shachi in the respect that this LifeVest Wearable Cardioverter Defibrillator is in fact a Class III medical device. In regards to potential challenges faced while trying to get this device approved, I believe that…   Read more»

A tend to agree with Roberto in my thinking that all products, regardless of need, undergo their respective life cycles. Most products will go through their cycles at a pretty ‘normal’ rate compared to niche and staple products. Highly specialized…   Read more»

Similar the Roberto’s example above, I have experience with method validation and verifications in my past work experience. At the pharmaceutical company I was working at one summer, I was tasked to optimize a method my company used to separate…   Read more»

I agree with the two above posts which state that he process and design verifications are done towards the end of the specified project.A successful validation program depends upon information and knowledge from product and process development. I would like…   Read more»

I tend to agree with kpr76 and Roberto Pineda here when they conclude that they are different in function yet noticeably similar in their overall end goals. The occupation “project manager” is a broad term that is used across the…   Read more»

When regarding all the different areas of interest that go into a Human Factor study including HF formation and HF validation, it is especially important to also consider the evaluation of Use-Related risk. The goal of use-related risk analysis will…   Read more»

In regards to the FDA guidelines posted by la82, I tend to personally agree with their overall classification of devices into SR and NSR classes. In addition, I would like to highlight that the decision boards pay special attention to…   Read more»

As touched upon by the 5 areas of Emotional Intelligence, (Awareness, Empathy, Regulation, Motivation, Social Skills) as explained by Daniel Goleman, I believe the single most important quality a project manager possesses is a superior ability to communicate. Communication in…   Read more»

My experience while working in industry centers around my time at Bristol-Myers Squibb where the entire department worked in primarily a project based environment. There was a common goal for the entire method and analytical development (MAD) department worked towards…   Read more»

Design Validation is the testing of a product to ensure that it meets the user’s needs along with its expected intended uses by the engineers. Specified operation conditions must also be followed. 1) Slide- This product would benefit clinical trials…   Read more»