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nsam9295
@nsam9295
Eminent Member
Joined: Sep 6, 2019
Last seen: Dec 8, 2019
Topics: 0 / Replies: 40
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RE: Restrictions for physician's gifts

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 f...

5 years ago
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RE: Advice before signing an NDA

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...

5 years ago
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RE: Written Agreement v/s Verbal Agreement

Both verbal and written consent or agreement has legal standing. However, verbal consenting requires a lot more effort to record and preserve. A writt...

5 years ago
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RE: Upper vs Middle Management.

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 nu...

5 years ago
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RE: Organization Type vs. Effectiveness

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. Ther...

5 years ago
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RE: Forming a Project Team

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...

5 years ago
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RE: Benefits of post-market surveillance

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 th...

5 years ago
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RE: Risk Identification

I am currently working in a university setting rather than an industry setting. Therefore, we will have a different approach however the main fundamen...

5 years ago
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RE: How to run a risk management meeting ?

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 ...

5 years ago
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RE: Design Transfer

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 manuf...

5 years ago
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RE: Making up tests for design verification and validation

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 ...

5 years ago
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RE: Consequences Of Insufficient Design Controls

Well, the possibilities are endless. Even with a well thought out design control documents, there are possibilities of things going wrong due to us be...

5 years ago
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RE: Combination Product Phase I clinical Studies

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...

5 years ago
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RE: Minutes for meetings

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 neces...

5 years ago
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RE: What are Design Controls?

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 i...

5 years ago
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