Medical Device Courses | jmbellanich | Activity

jmbellanich replied to the topic "Let's Be Motivated!!!" -

Mon, 26 Apr 2021 03:38:49 -0400

If I wanted to motivate my team members as a project manager I would want to talk to them about what motivates and try to act on that. This is because what each team member needs to be motivated will… Read more»

jmbellanich replied to the topic "Skills Learned in this Class" -

Mon, 26 Apr 2021 03:38:40 -0400

From this class, I learned that communication and planning are key to a successful project. The simulations and mini-sims have shown that with proper communication and proper planning the problems that occur can be solved effectively.

jmbellanich replied to the topic "What’s Your Motivator?" -

Mon, 26 Apr 2021 03:38:33 -0400

For me, I am motivated when the work I am doing is interesting and challenging. To give an example, I have been more successful on my college projects when I got to choose what I wanted to do compared to… Read more»

jmbellanich replied to the topic "Communication Management" -

Mon, 19 Apr 2021 03:27:18 -0400

For the first question I think that the project manager should coordinate communication between the upper management and the project team. For communication that is between the project team I think each team member is responsible for communicating with the… Read more»

jmbellanich replied to the topic "QA vs QC" -

Mon, 19 Apr 2021 03:26:57 -0400

Quality Assurance and Quality Control are the same in that they both have the output of an action which improves quality but what they look at. Quality Assurance looks at the entire process and makes sure that how you perform… Read more»

jmbellanich replied to the topic "Changining staff" -

Mon, 19 Apr 2021 03:26:29 -0400

If someone on the project team was no longer able to perform a critical task for the project, it will require a change to the original project schedule. To make sure that the delay is not too large, the options… Read more»

jmbellanich replied to the topic "Unexpected Time Delays - miniSim" -

Mon, 29 Mar 2021 03:38:43 -0400

When a project is planned, it is important to define what risks that you expect to encounter, the probability of them to occur, and the impact they will have on the project. This is used to create a risk management… Read more»

jmbellanich replied to the topic "Monitoring & Controlling Techniques" -

Mon, 29 Mar 2021 03:36:16 -0400

Of the monitoring and controlling techniques discussed in the lecture, the most essential of these seems to be the metrics which are used to determine the state of the project. By looking at the schedule and cost variance, a project… Read more»

jmbellanich replied to the topic "Closing Phase" -

Mon, 29 Mar 2021 03:35:38 -0400

I think that the most important part of the Closing Phase is the logging of lessons that were learned. This is especially important for projects that were closed prematurely, as the reasons for their failure can be learned from and… Read more»

jmbellanich replied to the topic "Executing Process" -

Mon, 15 Mar 2021 03:19:42 -0400

Even though the executing phase requires the most time and money, I still believe that the planning phase is the most important phase because it defines the rest of the project. To give an example, if there was a mistake… Read more»

jmbellanich replied to the topic "Scope Creep" -

Mon, 15 Mar 2021 03:19:14 -0400

Scope creep is a problem because it makes can delay a project by making the scope larger than what was originally in the project plan. To prevent this, there would need to be a system for making changes to the… Read more»

jmbellanich replied to the topic "Meeting Deadlines with Research" -

Mon, 15 Mar 2021 03:17:26 -0400

As a project manager, I would need to consult the gantt chart and use my negotiating skills to keep a project on pace. If a task was delayed or a complication occurred, the impact of the delay needs to be… Read more»

jmbellanich replied to the topic "Inputs for Design Input Document" -

Mon, 08 Mar 2021 02:00:17 -0500

For a design input document to be useful and efficient, I think that it would need to both meet customer needs and be feasible. Thus, I think that the groups that should have an input on the Design Input Document… Read more»

jmbellanich replied to the topic "Gantt chart" -

Mon, 08 Mar 2021 01:59:25 -0500

On a gantt chart, the order of which tasks are done are based upon the resources required and the prerequisite tasks. Tasks are done in parallel when they are not dependent on each other and they don’t require the same… Read more»

jmbellanich replied to the topic "Overlapping activities" -

Mon, 08 Mar 2021 01:58:58 -0500

I think that the longer a project goes, the smaller changes the project team can make to the schedule, budget, and design without consequence. To give an example, it would be difficult to change to make large changes to the… Read more»

jmbellanich replied to the topic "Most Important Phase" -

Mon, 01 Mar 2021 04:25:53 -0500

In a project, I think that the most important phase for a project’s success is the selection of members for the project team. This is because the quality of any other phase of the project will depend on the effort… Read more»

jmbellanich replied to the topic "Benefits of this course" -

Mon, 01 Mar 2021 03:58:58 -0500

In this course, the things I learned are FDA regulations and how these regulations affect the project management process. I did not know much about the FDA previously and taking this course has given a much better picture into how… Read more»

jmbellanich replied to the topic "Estimating Project Timeline" -

Mon, 01 Mar 2021 03:51:43 -0500

In the case that the original planned durations for tasks are not equal to the actual time it took for them to be completed, I think that the most effective tools a project manager has are the Gantt chart and… Read more»

jmbellanich replied to the topic "Communication and Responsiveness" -

Mon, 22 Feb 2021 02:42:09 -0500

If I needed to deal with members that are not cooperative or communicative as a project manager I would try to change the Communications Management Plan. The changes I would make would be to increase the frequency of project status… Read more»

jmbellanich replied to the topic "Underestimating Task Duration" -

Mon, 22 Feb 2021 02:41:54 -0500

As a project manager, I would think that the most important part of time management is getting a good estimate. The most common approach to getting an accurate estimate of the amount of time to complete a task is to… Read more»

jmbellanich replied to the topic "PM: Handling Team Issues" -

Mon, 22 Feb 2021 02:39:58 -0500

If I was a project manager tasked with dealing with changing personnel resources, the first step I would take is to consult the original project timeline, using the software that the company uses. Then, I would assess the impact that… Read more»

jmbellanich replied to the topic "Simulations" -

Fri, 12 Feb 2021 00:03:36 -0500

This week, I was in Group 3 for the first simulation. When deciding how to change the procedure for the verification test, there was two things that I noticed were different compared to face to face. The first thing I… Read more»

jmbellanich replied to the topic "Product Life Cycle" -

Fri, 12 Feb 2021 00:03:17 -0500

For the products that seem to not have a decline, I think that this is because each product has its own length for each of the different phases. For example, a product that seems to have no Decline phase might… Read more»

jmbellanich replied to the topic "Pros and Cons of the 3 Organizational Structures" -

Fri, 12 Feb 2021 00:02:55 -0500

Of the three organizational structures which we went over, I would favor the project-based structure because of the way communication and management are done. If I was working on a project, I would like to know every person working on… Read more»

jmbellanich replied to the topic "Safety Recalls" -

Mon, 08 Feb 2021 04:53:51 -0500

One of the FDA’s purposes is to ensure the safety and efficacy of medicine. This includes when the product is already on the market. One of the issues of a product on the market that needs to be faced is… Read more»

jmbellanich replied to the topic "Determining project priority" -

Mon, 08 Feb 2021 04:37:08 -0500

From the perspective of a project team member, I can understand how cancelling a project can seem wasteful. In my previous posts I have discussed how initiating a project can be the hardest step of a project. To abandon a… Read more»

jmbellanich replied to the topic "Possibility of Global Regulation of Medical Devices?" -

Mon, 01 Feb 2021 04:34:26 -0500

In the future, I do see there being a globalization of regulatory procedures. As for whether this would be a beneficial or not, I think it will because of how it will make medical devices globally available. This is because… Read more»

jmbellanich replied to the topic "Project Manager Skills" -

Mon, 01 Feb 2021 02:34:27 -0500

There are multiple skills that a project manager needs to succeed, but I think that the most important of these is being able to adapt to unforeseen problems. Almost all projects do not go exactly as planned and there are… Read more»

jmbellanich replied to the topic "Discussion Topic: Projects of all types" -

Mon, 01 Feb 2021 01:52:27 -0500

In my opinion how Project Management differs in different industries are the which steps need to be completed and the order in which they are done. This is because for each industry the technology is different and the goals (customer… Read more»

jmbellanich replied to the topic "Best timing for validation and verification" -

Mon, 25 Jan 2021 14:50:10 -0500

Looking up the definition of validation and verification, the FDA describes validation as proving that “specifications conform with user needs and intended use(s).” and verification as proving that “design output meets design input.” (Source: https://www.fda.gov/media/116762/download) My understanding of this is… Read more»

jmbellanich replied to the topic "Interpersonal skills vs technical knowledge" -

Mon, 25 Jan 2021 14:50:09 -0500

First off, I will agree with the view that colleges emphasize on technical knowledge over interpersonal skills. The best example of this is the emphasis on tests where your ability to memorize facts is more important than your communication skills…. Read more»

jmbellanich replied to the topic "Initiating a Project Idea" -

Mon, 25 Jan 2021 14:50:08 -0500

From my experience, the first step of a project is the hardest because it is the most open-ended. By this I mean that the amount of options that you must choose from is the greatest and among those choices it… Read more»