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sa2847 replied to the topic "Strategies to Counteract Negative Schedule Variance" – 3 days, 14 hours ago
In the medical device industry, dealing with a Schedule Variance (SV) – when a project doesn’t follow its planned timeline – can be quite tricky. This is due to the strict regulations, the importance of product quality and safety, and… Read more»
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ae365 replied to the topic "Personnel evaluation when succeeding project but delaying." – 3 days, 14 hours ago
I don’t think that just because there’s been a delay in the project then its necessarily a problem within the personnel. I think there are always some unforeseen circumstances or natural causes to delays that have nothing to do with… Read more»
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sa2847 replied to the topic "Monitoring and Controlling in a Project" – 3 days, 14 hours ago
Ensuring the medical device meets predefined quality standards is crucial. This entails thorough testing and validation of the device against international standards, such as ISO 13485 for medical devices, and regulatory requirements, like those set by the FDA in the… Read more»
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sa2847 replied to the topic "Leaders of Change Control" – 3 days, 14 hours ago
In most companies, changes must go through an approval process, especially when it comes to projects, IT, or software development. This follows the organization’s change management policy. The specific roles that approve changes can differ based on the type of… Read more»
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jbh8 replied to the topic "Verification & Validation NDAs" – 3 days, 14 hours ago
NDAs are ways to ensure a company’s confidential information about their product stays within their personnel and necessary external parties such as the FDA. As the previous user had stated, their use and what information they seek to prevent disclosure… Read more»
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ae365 replied to the topic "Email Communication" – 3 days, 14 hours ago
I think both methods of communication have their uses but I also think that teams is able to do everything email can do and also has a better communication aspect to it. Not only can you direct message and voice/video… Read more»
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ae365 replied to the topic "Success Rate of Projects" – 3 days, 14 hours ago
I feel like success can be kind of a subjective sense when we try to equate it to a project. When we think of the term in the literal sense, I would categorize success by whether or not the team… Read more»
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jbh8 replied to the topic "Transference of Risk in Medical Device Companies" – 3 days, 15 hours ago
Typically in the medical device industry, avoidance, mitigation, and acceptance are used as risk management approaches. Transference is uncommon. If used, as others have stated before, insurance is used as a means of transferring risk to another party. Another way… Read more»
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nm523@njit.edu replied to the topic "Leaders of Change Control" – 3 days, 15 hours ago
Most larger medical device companies have developed an ‘Approval Matrix’ that details out every potential type of change and document category (ex. change to material spec, process spec, risk document, etc) and based on this matrix you can see which… Read more»
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nm523@njit.edu replied to the topic "Monitoring and Controlling in a Project" – 3 days, 15 hours ago
An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity levels, and mitigation plans. Throughout the project, these risks may come to be… Read more»
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jbh8 posted a new topic "Monitoring and Controlling in a Project" – 3 days, 16 hours ago
This week, we learned about what would need monitoring and controlling in a project such as the schedule, budget, resources, performance, and scope. For example, the schedule can change when a part doesn’t arrive by its planned date. Thus, the… Read more»
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shahil replied to the topic "Success Rate of Projects" – 3 days, 16 hours ago
I think it is always important to do post mortems. From post mortems, you learn what happened, what worked, what didn’t work. This will allow you to better approach future projects. This will also help you approach projects that will… Read more»
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shahil replied to the topic "Penalization for Going Over Budget and Time?" – 3 days, 16 hours ago
In most companies, the employee will probably get penalized during bonus time. I don’t think most companies would actually penalize an employee, to be honest.
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shahil replied to the topic "Email Communication" – 3 days, 16 hours ago
You can have emails auto sort. This is actually very helpful. This saves hours in my day. You should try it. Once you start doing it. I highly doubt you will ever not use it.
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atk27@njit.edu replied to the topic "Leaders of Change Control" – 3 days, 16 hours ago
Yes, ensuring the safety and efficacy of medical devices is important, and change control plays a critical role in achieving that goal. The final approval authority typically rests with a Change Control Board (CCB) comprised of senior representatives from various departments… Read more»
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atk27@njit.edu replied to the topic "Email Communication" – 3 days, 16 hours ago
Project managers can reclaim their inbox with a strategic approach. Schedule specific times to check emails and ruthlessly prioritize them. They can leverage tools like filters, labels, and canned responses to automate organization and save time.Choosing between emails and Teams… Read more»
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es364 replied to the topic "Email Communication" – 3 days, 18 hours ago
I would rather interact via Teams since these platforms are ideal for brief exchanges, group discussions, and project collaboration because they provide real-time communication and file sharing options.On the other hand, emails are better suited for detailed communication or documentation…. Read more»
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es364 replied to the topic "Strategies to Counteract Negative Schedule Variance" – 3 days, 19 hours ago
I think the first thing to do is for the project manager to identify the root cause of the negative schedule variance (SV). After identifying the root cause, project managers can take a number of steps to mitigate the effects… Read more»
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es364 replied to the topic "Success Rate of Projects" – 3 days, 19 hours ago
In my opinion a very successful project is one that fulfills every objective perfectly. Also, I think that a successful project is one that is completed within the time limit and within the allocated budget. However, I think a project… Read more»
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ms2768 replied to the topic "Compromises in Conflict" – 3 days, 23 hours ago
The mini sim this week did a great job representing some of the ways to go about resolving time conflicts within the project timeline. From my experience within the industry and learning from the mini sim, I believe that being… Read more»
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