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mg482 replied to the topic "Medical Device Project" – 4 years, 4 months ago
we are at almost the end of the finishline, we get through the DID, DDP and the risk management plan, only thing left is to come up with a clinical protocol for the clinical study. The challenge that we face… Read more»
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mg482 replied to the topic "Discussion Topic: Your organizational type" – 4 years, 4 months ago
my current job is at a company that would be considered as a matrix organization. there is a chance to move from one group to the other, cross train of many different things and get involved in different projects. being… Read more»
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mg482 replied to the topic "Upper vs Middle Management." – 4 years, 4 months ago
with higher management roles it comes way more responsibilities that one might get overwhelmed with. Higher the managers position in the organization the more people they are incharged of. I would want to be working in the middle management role,… Read more»
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mg482 replied to the topic "What is a risk management file?" – 4 years, 4 months ago
A risk management file is where you would keep all the documents and files that are in regards to risk management of projects. Everything should be documented on the risk management file. this document is more like a living document… Read more»
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mg482 replied to the topic "Risk Management Tools" – 4 years, 4 months ago
I have not personally participated in the FMEA process, but normally in my company that works on the biologics FMEA process happens under upper management supervision. However, the process of FMEA starts with my team getting together in a group… Read more»
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mg482 replied to the topic "Manage Risk" – 4 years, 4 months ago
I can’t decide which one I would go with over the other, mitigation or acceptance. While mitigation could be the most effective way to save money and to mitigate around risks, in certain examples you could get away with just… Read more»
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mg482 replied to the topic "When is validation is not required?" – 4 years, 4 months ago
Verification is laying down the foundation of the validation. Verification makes sure the product works the product works the way it is supposed to. Validation test how well the product works and it is required to demonstrate tests on devices… Read more»
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mg482 replied to the topic "Important Part of DDP" – 4 years, 4 months ago
I agree with some of my classmates’ opinions, I don’t think I would say one part of the DDP is more important than the other. All the information provided in the DDP provides a well-established foundation to execute the project…. Read more»
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mg482 replied to the topic "examples of controlled device changes" – 4 years, 4 months ago
in research and production having document control is very essential. For example, if new people were added to the team and wanted to learn more about the project and its progress, they would be able to look back and see… Read more»
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mg482 replied to the topic "Minutes for meetings" – 4 years, 5 months ago
If you asked me before working for corporate I would probably say meeting minutes are just repetitive and there is no point for them if you already attended the meeting. However, they play such a big role in referencing certain… Read more»
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mg482 replied to the topic "Design Documents in Academia" – 4 years, 5 months ago
@sts27 I agree, in my opinion, I do think in academia different departments have different regulations. For example, I do believe the life sciences department could have different regulations than the engineering department. An example of regulation needed for engineering… Read more»
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mg482 replied to the topic "Verification Protocol" – 4 years, 5 months ago
Verification protocol is very essential to demonstrate the safety of the device on the user. an example would of a product that needs verification protocol before it is allowed for the public to use be the covid 19 vaccines. this… Read more»
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mg482 replied to the topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" – 4 years, 5 months ago
I disagree, pharmaceutical drugs can be used to cure certain diseases. those clinical trials are very essential to test the effectiveness of the drug. for example, medications that are heavily being used nowadays to help treat coronavirus have had great… Read more»
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mg482 replied to the topic "Discussion Topic: Having a "clinical background"" – 4 years, 5 months ago
the need of a clinical foundation relies upon the job that one chooses to follow. I would state that jobs in clinical research require a clinical foundation due to the job requirement to execute the tasks needed. This is an… Read more»
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mg482 replied to the topic "Clinical Studies" – 4 years, 5 months ago
Clinical trials are essential for testing new drugs, devices, and vaccines in development. People have signed up over many years to be subject of the test in clinical trials. While I understand the concern of the side effects that the… Read more»
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mg482 replied to the topic "Manipulation or no?" – 4 years, 5 months ago
that’s a tricky question, emotional intelligence could be manipulative if the sales rep isn’t honest or looking out for the consumers’ benefit. a successful sales rep knows how to provide the right consumer for the product with all the facts… Read more»
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mg482 replied to the topic "Sales vs project management" – 4 years, 5 months ago
I agree with @sallirab, for a successful project, the product manager and the sales rep have to be in sync and have proper communication. These two roles play the most important role in developing the product. the project manager is… Read more»
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mg482 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" – 4 years, 5 months ago
A successful project manager would make sure to include the sales rep from the beginning of the product planning phase because the sales rep would have a better idea of the consumers needs. it helps the company connects well with… Read more»
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mg482 replied to the topic "Partnership characteristics" – 4 years, 5 months ago
that depends, do I know the person I am going to have this partnership with? there are plenty of failed partnerships where one could lose everything they invested and the other partner would remain unaffected. Having a partner ideally would… Read more»
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mg482 replied to the topic "Accepting job based on company." – 4 years, 5 months ago
that’s an interesting topic to be brought up, I do believe I would accept or reject a job based on the company and the company reputation even if it means I would struggle to find for a bit, but at… Read more»
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