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mem42 replied to the topic "Discussion Topic: Course conclusion and impressions" – 5 years, 10 months ago
I am very glad I took this course. It gave me the overview I needed to understand more of how things work in the industry. I know certain topics are more complex than others and they could even take a… Read more»
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mem42 replied to the topic "Restrictions for physician's gifts" – 5 years, 10 months ago
I think the restrictions are not out of place. You are attending a business discussion and family members should not be involved. It should be understood in the doctor’s side that only his meal will be covered and therefore he… Read more»
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mem42 replied to the topic "Written Agreement v/s Verbal Agreement" – 5 years, 10 months ago
An oral agreement can include forms of oral agreement and a written contract. A verbal agreement is made without a formal written documentation. While the agreement is there and understood in spoken words it’s more difficult to prove in court…. Read more»
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mem42 replied to the topic "Upper vs Middle Management." – 5 years, 10 months ago
Personally, I think I would be suited for either one. Middle management is essential to understand the vision and I think this is where experience is very important. To begin my career I need to start in middle management so… Read more»
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mem42 replied to the topic "Forming a Project Team" – 5 years, 10 months ago
As it’s mentioned quite a few times in the previous posts, in a real-life scenario you most likely won’t have the opportunity to finger pick the persons you want to work with. I think, if you are given the task… Read more»
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mem42 replied to the topic "Discussion Topic: Your organizational type" – 5 years, 10 months ago
Previously I worked in a project-based organization. Although I was just an intern, I got to experience how the projects were worked out within the department. The projects I was involved in required numerous SMEs which at times was a… Read more»
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mem42 replied to the topic "Risk management and Labels" – 5 years, 10 months ago
Once the product is out in the market, and the company has done everything possible it is up to the user to use the product as indicated. The company should have written clear labels and directions as to how to… Read more»
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mem42 replied to the topic "How to run a risk management meeting ?" – 5 years, 10 months ago
Risk meetings should have an agenda that everyone is already aware of. This way all attendees know what the meeting will be about. I think breaking down the risks in categories is a good idea because people can focus on… Read more»
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mem42 replied to the topic "What is Risk-benefit analysis ?" – 5 years, 10 months ago
One of the factors is Assessment of the Benefits of Devices. In this assessment, the FDA takes into account the types of benefits that the device has on patient health as well as their satisfaction. The types of benefits can… Read more»
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mem42 replied to the topic "What are Design Controls?" – 5 years, 10 months ago
Design controls have a specific objective and its to assure that the device meets the user needs, intended uses and specified requirements. Design controls also serve as a way to continue improving the device and prevent future problems, FDA callbacks…. Read more»
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mem42 replied to the topic "Design input sources" – 5 years, 10 months ago
Design input sources can vary depending on what could be the most efficient way to obtain them. Many times, market analysis can offer significant information about a product. Technical research is also valuable to bring in an input of the… Read more»
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mem42 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" – 5 years, 10 months ago
I agree with the verification points mentioned above as well. Verification process makes an emphasis on attention to detail, to avoid major mistakes. Early verification can be helpful to study the product as well as ensuring all points are in… Read more»
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mem42 replied to the topic "Design Documents in Academia" – 5 years, 10 months ago
In research, documentation is also very important. Besides protocols, laboratory notebooks are highly useful because here it’s where you can find specifications of a procedure or a concept that can help people understand or have more efficient results. When I… Read more»
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mem42 replied to the topic "Customer Needs and Design Input" – 5 years, 10 months ago
Advantages of DID is that serves as an overall/general description of the product it also states the design input as clear and objective without numerical specifications. The major disadvantage with DID is that it’s too broad. Meanwhile, DSD captures numerical… Read more»
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mem42 replied to the topic "Minutes for meetings" – 5 years, 10 months ago
I agree that meeting minutes are highly useful. During my internship, I took minutes during meetings without being asked to. I found that directors liked that and complimented me to taking part in that. Sometimes you think you will remember… Read more»
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mem42 replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 5 years, 10 months ago
I firmly believe the consent is necessary. The patient has authority to say yes or no to what the hospital can do with their specimen. They can be informed of what the benefits are when saying yes, and how they… Read more»
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mem42 replied to the topic "Ethical Issues with Clinical Trials" – 5 years, 10 months ago
The ethics behind this sort of decisions are quite hard. If subjects are interested in research that has not been approved I think consent should be given only after they have been educated, informed, and fully capacitated of what the… Read more»
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mem42 replied to the topic "WHAT IS THE OBJECTIVE OF CLINICAL TESTING ON PHARMACEUTICA DRUGS?" – 5 years, 10 months ago
Clinical testing of pharmaceutical drugs is highly important. Drugs should undergo clinical trials to investigate their effect in the subjects, as well as any other changes such as secondary effects or healing curve. Even if you have the idea that… Read more»
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mem42 replied to the topic "The Expert" – 5 years, 10 months ago
Very comic sketch. I have to agree that in occasions working in the front end of customer services you can experience similar situations. You meet a customer, he then tells you what their needs it and what the final product… Read more»
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mem42 replied to the topic "Brand Coloring" – 5 years, 10 months ago
I think many brands like to use the red color because it expresses excitement besides hunger. Red color easily stands out, it’s bold and highly attractive. Coca-Cola has been using the red color to convey their message without using may… Read more»
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