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Jbarbee
@jbarbee
Trusted Member
Joined: Jan 17, 2022
Last seen: Dec 4, 2022
Topics: 0 / Replies: 78
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RE: Restrictions for physician's gifts

Great question! While paying only for the doctor may be very restrictive, I understand the point of not allowing these forms of compensation for physi...

2 years ago
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RE: Discussion Topic: Course conclusion and impressions

I must say, after taking two courses with Dr. Simon, his courses are one of a kind. Your typical course includes learning theories and understanding k...

2 years ago
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RE: Confidentiality Agreements

The confidentiality agreements are essential to protecting confidential information shared between companies. I agree with @kaf43. Certainly, the pay ...

2 years ago
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RE: Upper vs Middle Management.

Personally, I believe I would be best suited for a middle management role. Upper management typically require a certain level of "global" expertise an...

2 years ago
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RE: Project management

As discussed during lecture, the Design Development Plan should contain the Gantt Chart, WBS dictionary, Network Diagram, the budget, schedule, resour...

2 years ago
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RE: Ghantt Chart vs. Network Diagram vs. Other?

The Gantt Chart is a visual representation of project schedules whereas the Network Diagram is a representation of project workflow. The Gantt Chart m...

2 years ago
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RE: Manage Risk

For risks of low severity, as there is minimal threat, risk acceptance may be the best option. Depending on the threat posed, one may choose risk miti...

2 years ago
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RE: Dealing with risk

An instance where the risk is worth acceptance is when dealing with biologics in medical device development. While biologics such as vaccines, gene th...

2 years ago
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RE: Hazard, Hazardous, Harm

An example of a hazardous situation is the exposure to many biohazards and chemicals within the laboratory. Inside of the laboratory, professionals de...

2 years ago
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RE: Design Controls: What do you deem most important?

I believe the user/customer feedback is the most important aspect in design controls. When companies consider the needs of the customer, it displays t...

2 years ago
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RE: Design Transfer and Challenges

Other challenges that may occur in design transfer include incomplete manufacturing instructions, errors or an incomplete design documents, lack of in...

2 years ago
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RE: Design input sources

The main source for the design input comes from marketing. During product development, design controls are compiled based on market need for the produ...

2 years ago
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RE: Minutes for meetings

Meeting minutes are essential in keeping record of meetings. During these meetings, critical information is discussed such as any modifications to the...

2 years ago
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RE: Validation failure

As a validation engineer, I think the first step after a failed validation is to question why the product failed validation. Depending on what it is t...

2 years ago
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RE: Customer Needs and Design Input

The Design Input Document (DID) provides the physical appearance and basic performance of a device. The Design Specification Document (DSD) is a detai...

2 years ago
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