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jbh8
@jbh8
Estimable Member
Joined: Sep 9, 2023
Last seen: Apr 14, 2024
Topics: 24 / Replies: 47
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RE: Design Controls Component

Of the nine components, the three most interesting ones are: inputs, design history file, and planning. Inputs are essential to the overall success of...

1 year ago
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Replies: 6
Views: 390
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RE: Balancing Scientific Rigor and Ethical Considerations in Clinical Trials

One consideration taken should be the benefit-risk ratio. Researchers should determine whether the benefits outweigh the risks by asking whether risks...

1 year ago
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RE: Scenarios if internal & external environments

A medical device company based in Florida launches a novel commercial IUD with a biodegradable polymer coating. The company had hired subject matter e...

1 year ago
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RE: Digital Marketing

Although the internet has definitely widened its customer reach through digital marketing, the digital divide should be considered. The digital divide...

1 year ago
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Replies: 6
Views: 530
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RE: Ethics of Corporation considered as an entity

As previous replies had stated, the corporate veil’s purpose is to separate the corporation and their shareholders; it essentially protects shareholde...

1 year ago
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Replies: 18
Views: 1153
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RE: 80% margin

Like previous replies, I also believe it is unethical life-saving technology potentially may be disregarded if the profit margin is under 80%. A few r...

1 year ago
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RE: QA/QC Audits

In a way, the audits performed by regulatory agencies are a way to measure the performance of the QA and QC departments. However, I would also argue t...

2 years ago
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RE: Items Affecting Quality

While working as an intern for a commercial technical operations team, I was exposed to the change control process. The company I worked for had been ...

2 years ago
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RE: FDA vs EMA drug approval rate

I agree with points made above by previous users including the difference in review process. I particularly want to expand on the point regarding the ...

2 years ago
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