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kk posted a new topic "In case of recall" – 5 years, 10 months ago
I know this lecture did not touch much of product recall. But, how should company/researcher response when there is recall request from FDA or other regulations? Are there different stages of severity of recall and how to react?
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kk posted a new topic "Human resource management" – 5 years, 10 months ago
I have one scenario I wonder about what happens in this case In human resource management, a team has been settled and worked on a project and in the middle of the process. The project should keep moving on to… Read more»
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kk posted a new topic "Gantt chart" – 5 years, 10 months ago
On the gantt chart, why is it important to have multiple overlapping tasks going on in parallel? I understand within a same category, to make a smooth and fast work process, tasks overlap and process in parallel. But why does… Read more»
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kk posted a new topic "Medical device" – 5 years, 10 months ago
As far as I know, bandage should be gone through 510K or regulated by FDA. It sounds like it is categorized as a medical device. But it is not for diagnose tool, treat disease or affect structure in human. Not… Read more»
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kk started the topic In case of recall in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
I know this lecture did not touch much of product recall. But, how should company/researcher response when there is recall request from FDA or other regulations? Are there different stages of severity of recall and how to react?
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kk started the topic Human resource management in the forum Project Management Knowledge Areas 5 years, 11 months ago
I have one scenario I wonder about what happens in this case
In human resource management, a team has been settled and worked on a project and in the middle of the process. The project should keep moving on to finish by deadline. One of team member is having maternity leave for 3 months. She is the only one who knows how to deal with her work. In…[Read more] -
kk started the topic Gantt chart in the forum Project Management Process and Medical Device Development 6 years ago
On the gantt chart, why is it important to have multiple overlapping tasks going on in parallel? I understand within a same category, to make a smooth and fast work process, tasks overlap and process in parallel. But why does it also same for within different categories?
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Ka Kyung Kim started the topic Medical device in the forum Introduction to Project Management 6 years, 2 months ago
As far as I know, bandage should be gone through 510K or regulated by FDA. It sounds like it is categorized as a medical device. But it is not for diagnose tool, treat disease or affect structure in human. Not all of products getting 510K are not medical device or they are still medical device?