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Talha Chaudhry replied to the topic "General Wellness Product" – 5 years, 10 months ago
I’m actually using this biomedical device for my capstone project. It’s called the comfortprene wrist and thumb-wrap. It’s a general wellness product that would fall into the second category of the FDA’s definition of said general wellness products. The reason… Read more»
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Talha Chaudhry replied to the topic "Toxic Medicine" – 5 years, 10 months ago
The design controls that could potentially be visited do include DID, DDP, DSD, verification/validation protocols, risk analysis, and risk management. However, since this is a homeopathic product, the FDA has less oversight on it than say a injectable vaccine. A… Read more»
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Talha Chaudhry replied to the topic "How to initiate project successfully" – 5 years, 10 months ago
From my experience, the initiation process can be divided into 4 phases for project management: Objectives: The first phase involves creating an objective(s). This is where you determine what information you need about from the project so that they can… Read more»
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Talha Chaudhry replied to the topic "Validation vs. Verification" – 5 years, 10 months ago
I have an example I can share based on the definition you give. Take a smartphone for example, focusing mainly on the touch-screen interface. Validation processes would involve making sure that the pressure exerted on the display would translate from… Read more»
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Talha Chaudhry replied to the topic "Difference" – 5 years, 10 months ago
I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsibilities of a CPM: -Leads… Read more»
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Talha Chaudhry replied to the topic "Significant or non-significant risk" – 5 years, 10 months ago
Going of la82’s post, I think the way the FDA defines the line between a device of significant and non-significant risk is blurry. I think this guideline especially raises a few concerns: • Otherwise presents a potential for serious risk… Read more»
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Talha Chaudhry replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago
I have not worked in industry before, nor do I have experience in any type of the organizations listed. If I were to go into industry, I would feel more gravitated towards a project-based organization. The structure of working in… Read more»
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Talha Chaudhry replied to the topic "Project Manager Skills" – 5 years, 10 months ago
I agree with the all the skills that Dr. Simon mentioned in the lecture, and I would like to add another important skill a project manager to possess. This skill can fall under awareness, but I believe it deserves great… Read more»
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Talha Chaudhry replied to the topic "Discussion Topic: To trial or not to trial" – 5 years, 10 months ago
Design Validation is the assurance that the product is able to meet the needs of the customer and is in accordance with expectations set by the engineers responsible for creating the product. It involves acceptance and approval from third parties… Read more»
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Talha Chaudhry posted a new topic "Disconnect in rewarding motivation" – 5 years, 10 months ago
In Dr. Simon’s Lecture from last week, he points out the disconnect in how the industry rewards motivation as compared to our own perspective. As employees, we hope for ‘teamwork’, ‘achieving challenging stretch goals’, and overall ‘candor’ to motivate us…. Read more»
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Talha Chaudhry posted a new topic "Why do people leave work?" – 5 years, 10 months ago
So, this is essentially a follow-up to my previous post of ‘Why do people work?’. On one of the lectures Dr. Simon posted, there was a survey that said “‘limited recognition and praise’ was cited as the most common reason… Read more»
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Talha Chaudhry posted a new topic "Why do people work?" – 5 years, 10 months ago
For the lecture this week, I was fascinated by the results of the study Dr. Simon referenced. The study asked employees why they stayed and worked at the company they are employed at. What motivates them kind of surprised me…. Read more»
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Talha Chaudhry posted a new topic "Change Requests During Clinical Trials" – 5 years, 10 months ago
When a project reaches clinical trials, I can imagine the morale of the project team being very high as they have created a working device that was proven to work and sent off for “testing”. Sometimes, as Dr. Simon mentioned,… Read more»
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Talha Chaudhry posted a new topic "Design Review Meeting Culture" – 5 years, 10 months ago
During a design review meeting, the project team meets to approve documents and decide on whether to move on to the next stage. Documents are reviewed beforehand, and any changes are brought up during the meeting. Now what is interesting… Read more»
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Talha Chaudhry posted a new topic "Device Class Confusion" – 5 years, 10 months ago
I’m about to finish up a senior project and about to demo it very soon. One of the assignments I needed to complete was to classify the device based on what the FDA would think of my device. At first… Read more»
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Talha Chaudhry posted a new topic "Variance During M&C" – 5 years, 10 months ago
During the monitoring & controlling phase, you can perform variance analysis to determine the worth of your project at certain points of the schedule. Schedule variance is the difference between earned value and planned value. If your schedule variance is… Read more»
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Talha Chaudhry posted a new topic "PM: Quality Assurance Process" – 5 years, 10 months ago
As a PM, quality assurance is a huge responsibility. What are some tasks that you would need to perform to obtain accurate assessment of quality assurance of your project? Once you have the results, how would you proceed from there?… Read more»
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Talha Chaudhry posted a new topic "PM: Handling Team Issues" – 5 years, 10 months ago
One of the interesting things that Dr. Simon mentioned in this weeks lecture was the concept of team development. When you are a project manager, your project team is not composed of robotic entities. They are human beings who can… Read more»
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Talha Chaudhry posted a new topic "Thalidomide's Impact on Regulation and the FDA" – 5 years, 10 months ago
As Dr. Simon pointed out in his first video, it is important to understand the history of the FDA when learning about regulation. One event I would like to highlight is the thalidomide scandal of 1962. Thalidomide was a sedative… Read more»
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Talha Chaudhry replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 7 years, 11 months ago
To build off what you said, the venture supervisor can be a surprising huge motivator. To know that someone believes in what you can do so much to put forth a lump sum to create a product greatly validates your own abilities as an engineer even further and pushes you to perform at a high level. Those high expectations eventually become more of a…[Read more]
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