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lianhuajin replied to the topic Corporate Veil in the forum Business 101 7 years, 5 months ago
when court will pierce the corporate veil? I googled it and Courts might pierce the corporate veil when all of the following are true.
Firstly, there is no real separation between the company and its owners. If the owners fail to maintain a formal legal separation between their business and their personal financial affairs, a court could find…[Read more] -
lianhuajin replied to the topic Public vs. Private Companies in the forum Business 101 7 years, 5 months ago
A public corporation is a business whose securities are traded on the public stock exchanges. A private company is held solely by its owners and is not traded publicly.
A big difference between private and public companies involves public disclosure. A public U.S. company trades on a stock exchange and must file quarterly earnings reports with…[Read more] -
lianhuajin replied to the topic Types of Corporations in the forum Business 101 7 years, 5 months ago
I would want to be an owner of LLC in the US because of these benefits. First of all, there is no residency required, owners of an LLC do not have to be U.S. citizens or permanent residents. I am a foreigner so this part is very important. Secondly, It has legal protection, owners of an LLC have limited responsibility for business debts and…[Read more]
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lianhuajin replied to the topic R&D vs Quality in the forum Quality Control and Quality Assurance 7 years, 6 months ago
I searched about this title and found that there is the potential for misalignment and conflict when the quality function and the R&D function are divided in two separate organizations, often with different objectives and performance measures. The danger comes when R&D folks start to see themselves as less responsible for product quality as they…[Read more]
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lianhuajin replied to the topic Regulations with quality in the forum Quality Control and Quality Assurance 7 years, 6 months ago
The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s)
I found the types of CGMP Drug Inspections online.
• Surveillance Inspections
– Risk-based frequency
– Sites selected by risk model and local judgment
• For-Cause (Compliance) Inspections
– Local/HQ/…[Read more] -
lianhuajin replied to the topic What are some ways Document Control can improve? in the forum Quality Control and Quality Assurance 7 years, 6 months ago
I will talk one way I think can improve document control.
That is promoting training and documentation.
Every employee charged with handling some form of document should be trained in content management and proper handling policies as determined by credit union policy. Processes may differ slightly from the lending and member service areas, which…[Read more] -
lianhuajin replied to the topic Discussion Topic: Android app for measuring blood glucose in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I searched about the app for measuring blood glucose. Philosys, secured approval from the U.S. Food and Drug Administration for a portable blood glucose meter that hooks into Android devices through the headphone jack. It had previously received 510(k) clearance for a version of the device for iOS network devices.
Philosys is part of a broader…[Read more] -
lianhuajin replied to the topic Discussion Topic: The de Novo 510(k) Process in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
“De Novo” pathway- Established by the Food and Drug Administration Modernization Act of 1997 to provide a new mechanism for reclassification of certain lower risk devices from class Ⅲ to class ⅠorⅡ.
Examples of De Novos Granted for Devices Presentng More Than Low Risk
De novo pathway is not just for low risk devices—
1. Neurovascular mechanical…[Read more] -
lianhuajin replied to the topic Discussion Topic: e-cigarettes in the forum Regulatory Basics for Medical Devices 7 years, 6 months ago
I saw an interesting news about e-cigarette that teens actually using e-cigarette more than tobacco cigarette. and the trend is growing. And the Center of the Disease says now teens using vaporizers three times more than they did in the 2012. The liquid used in the e-cigarette has different flavors like berry, mango, grape, and those flavors…[Read more]
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lianhuajin replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 7 years, 6 months ago
Doing a research by using animal model may be cruel, but we do not have other options which are better than this one. Maybe in the future, people can make some biological robot which can be used in the biology research. Or maybe in the future, people can print out organs by using 3D print and then we can use these organs in the study. But we need…[Read more]
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lianhuajin replied to the topic Academia vs. Industry Research in the forum Pre-clinical Device Development 7 years, 6 months ago
I had no opportunity to do industry research, but I can feel that money is the most important thing that people care about in the industry research.When I worked in academia research, I found that people more care about having good papers. Basically, the fundamental goal of both researches are making money. No money, No research. But the reason…[Read more]
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lianhuajin replied to the topic Research for the Fututre or Now? in the forum Pre-clinical Device Development 7 years, 6 months ago
I prefer doing research which can help present generation, since it can not make sure what is going to happen to next generation。 If we can’t solve the problems for present generation, the problems would pass down to the next generation. And also people have more passion to work for current problems. If someone let me do something for the future d…[Read more]
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lianhuajin replied to the topic Obstacles while working on a project in the forum Intro to Project Management 7 years, 6 months ago
The obstacle I met when I was working on a project was the discrepancy between the members. It is very usual that one group of members have more than one opinion on the same things. And everyone think their opinions are right. Nobody would say” Mine is wrong”. So then they will discuss, but sometimes the discussion does not go well. Some people…[Read more]
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lianhuajin replied to the topic Project Life Cycle in the forum Intro to Project Management 7 years, 6 months ago
I think the most important phase is planning phase since a plan can decide many things. Good plan can save time, save budget and also save energy. If you have good plan, your project is more likely to success. Also the plan should be flexible, because it is inevitable to change the plan in different situation.
I think all phases are important,…[Read more] -
lianhuajin replied to the topic Project Manager Experiences in the forum Intro to Project Management 7 years, 6 months ago
In my opinion, Manager does not need to have more knowledge than their members. I met a few managers before, they do not know more than their members, they can be the manager of the team may be because they have more work experience. Jack Ma, he is the founder of ALibaba Group. He said he knows nothing about IT, but he is one of the famous…[Read more]
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lianhuajin replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 7 years, 6 months ago
I think both are important, but, in fact, there is limited practical courses in the school, and I do not know why? We learn engineering and in this area, I think, problems always come from practice or not papers. Sometimes it is theoretically reasonable, but when people put it into practice, it is not goes well, and they can not figure out the reason.
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lianhuajin replied to the topic Discussion Topic: Academia vs. Industry in the forum Introduction to Medical Device Development 7 years, 6 months ago
I prefer industry over academia, as I learned in the course, we can earn more money from industry. Besides, industry is about marketing and I love marketing. But I feel that industry requires more from their employee. I saw many people who worked in the industry move to the academia now. They were not fired but laid off because of company’s…[Read more]
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lianhuajin replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 7 years, 6 months ago
Yes. Do an internship is very important. Since we spent so much time in the school, and what school can give us is limited. We need other way to learn something that we can not learn from school and in this case internship is an very good option. I get it when I worked in a lab in the NJMS as an Internship, I learned a lot besides knowledge, I…[Read more]
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lianhuajin became a registered member 7 years, 6 months ago