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tn58 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
Deadlines motivate me to finish my work on time. As a project coordinator, my entire program is run on a deadline as well as the work breakdown structure for everyone. I make sure all of the tasks are completed 1 day before the deadline and this tool has helped me achieve majority of expected results in this program. Each person is assigned…[Read more]
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tn58 replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
Project managers motivation is critical in a team. Each team member needs to look up to the project manager and be comfortable with the deadlines, and tasks assigned. As a project manager, your motivation, your time management skills and your interpersonal skills will play a major role in how well your team performs. For example, my only project…[Read more]
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tn58 started the topic CROs in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
CROs are Contract Research Organizations that provide support to companies for their research services as outsourced contract based.
As mentioned in the lecture, the sponsor usually transfers one or more of his/her responsibilities to these CROs. Out of all the responsibilities that Dr. Simon listed, which ones would a good sponsor never…[Read more]
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tn58 started the topic CROs in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
CROs are Contract Research Organizations that provide support to companies for their research services as outsourced contract based.
As mentioned in the lecture, the sponsor usually transfers one or more of his/her responsibilities to these CROs. Out of the responsibilities that Dr. Simon listed, which ones would a good sponsor never transfer…[Read more]
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tn58 started the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
As the lecture focused heavily on the consent portion, and addresses that clinical trail cannot take place if it is known before time that death is a possible outcome. This had me wondering, how can you possibly predict that before hand? Isn’t there always a margin or error in animal studies vs. human studies. They don’t necessarily have the give…[Read more]
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tn58 replied to the topic Non-Conformity in the forum Quality Systems Management 7 years, 12 months ago
In addition to your the previous input, it would depend on the type of nonconformity. For example, after googling examples. I became aware that that there are three types of nonconformities: minor, major, and critical.
Minor nonconformity would be when the durability, interchangeability, reliability, maintainability, or effective use of a…[Read more]
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tn58 replied to the topic CAPA in the forum Quality Systems Management 7 years, 12 months ago
Agreeing with neb2, I would add that it order to simply put it in words and grasp it. It is a system that is used to avoid or eliminate undesirable outcomes or events. It is there to make sure we do not end up with any risk. In order words, it eliminates or reduces the probability of a undesired consequence and in return our company, product,…[Read more]
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tn58 replied to the topic Audits in the forum Quality Systems Management 7 years, 12 months ago
As the person above me went into great detail about the pros and cons of internal audits. I will add that it depends on the company you are working with. Some companies may play tricks to hide any inefficiencies while others will audit in great lengths. Here is the benefit of doing a fair unbiased internal audit. In the long run, the company will…[Read more]
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tn58 started the topic Organizational structure in the forum Project Management Knowledge Areas 7 years, 12 months ago
Human resource management part of the lecture focuses on project interface, staffing requirements, and constraints. In the constraints, it talks about organizational structure and describes weak vs. strong matrix.
For example, how much power the project manager has over his team. Can a director of a another department take away one of your team…[Read more] -
tn58 replied to the topic Integration PM in the forum Project Management Knowledge Areas 7 years, 12 months ago
One of my CAD projects was modeling a hip stem implant. This one project turned into two different projects. Initial project was to make a 3D hip stem implant using creo and focus on design specification and just created a 3d model for my orthopedics course. And my second project was for ANSYS where I had to do finite element analysis on a model.…[Read more]
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tn58 replied to the topic Discussion Topic: Scope creep….when your project changes in the forum Project Management Knowledge Areas 7 years, 12 months ago
I am a project coordinator for the ELA program. The program was initially started to put students with below a 2.5 on a academic probation list and to hire tutors specifically these students. This would allow the students to make appointments with tutors just for them and help them excel in their academics. This program is funded by the new jersey…[Read more]
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tn58 replied to the topic No GMPs in the forum Quality Systems Management 8 years ago
Agree with your input. This takes us back to the importance of GMPs. Yes they may be time consuming and hectic but the people who came up with GMPs did it for a reason. If there was no GMPs or if companies had a choice then they would only look at the business side of things and not worry about ethics. There are companies who if given the choice…[Read more]
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tn58 started the topic No GMPs in the forum Quality Systems Management 8 years ago
After going through the lecture and reading Dr. Simon’s post, i became curious. What if there were no GMPs?
For example, what if you had a choice between GMP or no GMP. What would you do with this option? What are some advantages and disadvantage in this case.Please share your experience or thoughts.
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tn58 replied to the topic Discussion Topic: Vagueness of GMP's in the forum Quality Systems Management 8 years ago
I do not agree that they make the process more difficult for companies or set companies up for initial failure. I think they are essential in order to succeed in the long run. If these GMPs did not exist then any product or company could be in the market and increasing revenue. Regardless how hectic and difficult your job becomes because of GMP,…[Read more]
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tn58 started the topic Ideal PM Processes vs. Real life in the forum Project Management Process and Medical Device Development 8 years ago
As we learned the Project Management processes over the past few lectures:
Initiating Processes, Planning Processes, Executing Processes, Closing Processing
Each process was very well defined and given certain inputs/outputs and what is done during each phase.My question for everyone working in the industry is how closely are these processes…[Read more]
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tn58 replied to the topic Design Review Meeting Culture in the forum Project Management Process and Medical Device Development 8 years ago
I don’t have any experience working in the industry. But I will add that each company is different. From my graduate students who worked in the industry each share a different point of view depending on the company they work for or the team they work with. Some people had a open communication in the meeting where all inputs were taken into…[Read more]
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tn58 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years ago
One example of product risk would be failing of a software used in a product. As an engineer, I would verify and validate the software used in the product during the executing process. Once the software is validated, any component of it used in the product would not raise a doubt or risk later on in the project. Also, as a part of the team I would…[Read more]
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tn58 replied to the topic Interpersonal Skills in the forum Product Life Cycle and Product Management 8 years ago
Thank you everyone for sharing your response. Glad to hear everyone agrees with my original post. Adding to that, I will definitely agree with jnm22 that both are essential and that interpersonal skills do tend to weigh more regardless of your technical knowledge of the product. Because many people like Bill Gates are the most successful people in…[Read more]
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tn58 replied to the topic Product Life Cycle Curve in the forum Product Life Cycle and Product Management 8 years ago
Agreeing with everyone above, I will add that yes some products do not follow the traditional path. Some products may not cost you a lot during any of the phases and end up giving you the most increase in sales and profit at the end. While some products may be very expensive during the research and development phase and you think everything is in…[Read more]
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tn58 started the topic Interpersonal Skills in the forum Product Life Cycle and Product Management 8 years ago
As we do this week’s simulation, we see that it requires the team members to use their Interpersonal skills to make a deal as well as the background information and business knowledge to make the best deal.
My question to you is, can a team leader make a deal only based on his or her interpersonal skills where he takes the customer in confidence…[Read more]
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