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nsam9295 replied to the topic "Restrictions for physician's gifts" – 5 years, 3 months ago
It may seem restricted, however, I would like to offer a different perspective towards these restrictions. Let’s say there are two companies who are fighting for one physician to consult with. Company A is a gigantic firm with a lot… Read more»
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nsam9295 replied to the topic "Advice before signing an NDA" – 5 years, 3 months ago
Like all legal documentation that binds you to a legal contract. It is extremely important for you to read through the whole documentation and you 100 percent agree and understand all there is written in the agreement. And if it… Read more»
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nsam9295 replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 3 months ago
Both verbal and written consent or agreement has legal standing. However, verbal consenting requires a lot more effort to record and preserve. A written agreement both parties sings the original documents and both keep the documentation. Whereas verbal agreement can… Read more»
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nsam9295 replied to the topic "Upper vs Middle Management." – 5 years, 4 months ago
I believe I would have the skill set to excel in both roles however I think I will enjoy it more if I work as upper management. And since there are numerous studies where if you do what you like… Read more»
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nsam9295 replied to the topic "Organization Type vs. Effectiveness" – 5 years, 4 months ago
There is no perfect organization type which will be the gold standard. In addition, there is a lot of factors that can affect efficiency as well. Therefore it is important you discuss the method that has previously worked before to… Read more»
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nsam9295 replied to the topic "Forming a Project Team" – 5 years, 4 months ago
It is important to first have a great project leader with lots of experience with managing people. I strongly believe that one of the main jobs of the project leader is to manage team members and also play a support… Read more»
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nsam9295 replied to the topic "Benefits of post-market surveillance" – 5 years, 4 months ago
Like in the lecture the risk management process should be designed in a way where it starts at the very beginning of the project to the end of when the product’s life ends. Especially for medical products. PMS I think… Read more»
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nsam9295 replied to the topic "Risk Identification" – 5 years, 4 months ago
I am currently working in a university setting rather than an industry setting. Therefore, we will have a different approach however the main fundamental idea is the same. For lab settings, we do a more concentrated dive in literature and… Read more»
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nsam9295 replied to the topic "How to run a risk management meeting ?" – 5 years, 4 months ago
I believe it is important to have each department send a representative to the meeting. That way when brainstorming and finding risk it will be a lot more efficient and effective. That way the project manager is able to have… Read more»
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nsam9295 replied to the topic "Design Transfer" – 5 years, 4 months ago
I would like to point out a crucial point. The manufacturing process or the design transfer success rate will depend on how well the outsourcing manufacturing factory understands the steps before the design transfer phase. In other words, no matter… Read more»
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nsam9295 replied to the topic "Making up tests for design verification and validation" – 5 years, 4 months ago
Since a lot of ppl touched on the FDA portion of the question, I will try to help you understand the other portion of your question. In theory, there are unlimited ways to test if the product is safe by… Read more»
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nsam9295 replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 4 months ago
Well, the possibilities are endless. Even with a well thought out design control documents, there are possibilities of things going wrong due to us being human beings and not able to predict all the possible outcomes. The only job of… Read more»
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nsam9295 replied to the topic "Combination Product Phase I clinical Studies" – 5 years, 5 months ago
I believe design control should be implemented in every step of the process from start to end of the product’s life. It is important to numerically or for some cases observationally be able to determine how well you are doing… Read more»
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nsam9295 replied to the topic "Minutes for meetings" – 5 years, 5 months ago
I believe some way to record what has been discussed in meetings are extremely important in terms of team success and organizations. It does not necessarily have to be in minutes. However, it is one method where one can read… Read more»
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nsam9295 replied to the topic "What are Design Controls?" – 5 years, 5 months ago
For any new device, it should be good practice to always have a way to test and minimize errors or risks before the product is sold to customers. It is extremely important to do this before and well. Since once… Read more»
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nsam9295 replied to the topic "Discussion Topic: Having a "clinical background"" – 5 years, 5 months ago
Any job in the world does not require previous experience to be good at. The main advantage for people who are hiring is that if someone has previous experience the time required for them to train them decreases significantly. Also,… Read more»
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nsam9295 replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" – 5 years, 5 months ago
Placebo is being used extensively in the field of pharmaceutical clinical trials. It is important to acknowledge that the extent of how the human mind places a role in affecting the human body both positively and negatively. And the only… Read more»
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nsam9295 replied to the topic "Clinical Trial Roles" – 5 years, 5 months ago
I would like to be a Research Assistant. This is more for Ph.D. students in a lab setting. Where the PI(Principal Investigator). Since I believe it is a high return for low risk. Depending on your P.I. you are able… Read more»
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nsam9295 replied to the topic "Advertising" – 5 years, 5 months ago
This all depends on the person and what they like. Due to the development of social media and the internet. Advertisements have changed and it has such a diverse form as well. I am not a big fan of advertisements… Read more»
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nsam9295 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" – 5 years, 5 months ago
A lot of marketing espcially these days applys a lot of what is being researched in the psychological field. These days a lot of advertisements are made with a psychological research background. Human brains are complex especially the unconsciousness of… Read more»
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