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ih37
@ih37
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Joined: Sep 14, 2018
Topics: 0 / Replies: 78
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RE: Best timing for validation and verification

The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verific...

6 years ago
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RE: Design Control Process

I currently work in manufacturing/production at a cell-research company where I process autologous cell-therapy products that is in its clinical phase...

6 years ago
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RE: Initiating a Project Idea

As we learned in lecture, all projects have a life cycle that dictates how smoothly the design process is going to flow, which in turn determines the ...

6 years ago
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RE: Product PMOA Classification with FDA Branches

The Ellipta inhaler is considered to be a combination product in the same sense that a pre-filled syringe is. The Ellipta inhaler contains a drug tha...

6 years ago
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RE: Categorization of Medical Devices

A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows on...

6 years ago
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RE: ''Quality Plan'' meaning ?

A quality management plan is defined in our PMBOK guidebook as "a component of the project or program management plan that describes how an organizati...

6 years ago
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RE: Project Manager Skills

A general online look at job openings for project managers (PM) lists a variety of skills ranging from interpersonal leadership skills to math-based a...

6 years ago
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RE: Should Interpersonal skills be more valuable than technical skills?

I believe that in a perfect world, the ratio of success between interpersonal skills and technical knowledge should favor technical knowledge, especia...

6 years ago
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RE: Discussion Topic: State of your Organization

The company that I currently work at would be considered a project-based organization in that we conduct research on cell therapy-based products and p...

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

I think it's quite clear that it is always more important to have an agreement transcribed into writing rather than have it established verbally, espe...

6 years ago
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RE: Contract Laws

I work at a clinical research company that is involved with recent breakthroughs in immunotherapy. This includes treating conditions such as cancer, ...

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

As a master's student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternat...

6 years ago
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RE: Project Management Preferences

The role and responsibilities of a project manager easily varies depending on which organizational type they are placed in along with their preferred ...

6 years ago
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RE: Effective way to culminate inter department silos

According to lecture, information silos are most prominent in functional organizations, meaning that the departments and project teams within the orga...

6 years ago
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RE: Discussion Topic: Your organizational type

The company that I currently work at would be considered a project-based organization considering that we conduct research on cell therapy-based produ...

6 years ago
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