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thuytienlecao replied to the topic "What FDA Looks For In A Design Control System ?" – 5 years, 10 months ago
@ppp23: if you are asking about what it is, it stated on that document that “Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design… Read more»
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alexandrabuga replied to the topic "Clinical Trial Roles" – 5 years, 10 months ago
If it was a sponsored clinical trial, I would be the sponsor as @ppp23 and @mark mentions, the sponsor selects the PI, prepares and submits clinical trial application and amendments to the appropriate regulatory agencies and ensures that the clinical… Read more»
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thuytienlecao replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" – 5 years, 10 months ago
I agreed with previous posts (from @aaq2 & @ppp23 …) about the definition of EI, the importance of EI in marketing and Kidwell’s paper. I also think that EI is essential in marketing However, I would like to add a… Read more»
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thuytienlecao replied to the topic What FDA Looks For In A Design Control System ? in the forum Introduction to Design Controls 7 years, 5 months ago
@ppp23: if you are asking about what it is, it stated on that document that “Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling,…[Read more]
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alexandrabuga replied to the topic Clinical Trial Roles in the forum Clinical Research Basics 7 years, 5 months ago
If it was a sponsored clinical trial, I would be the sponsor as @ppp23 and @mark mentions, the sponsor selects the PI, prepares and submits clinical trial application and amendments to the appropriate regulatory agencies and ensures that the clinical study is conducted in accordance with Good Clinical Practices (GCP). I think its exciting to have…[Read more]
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thuytienlecao replied to the topic Discussion Topic: Emotional Intelligence and its affect on sales in the forum Marketing and Sales 7 years, 5 months ago
I agreed with previous posts (from @aaq2 & @ppp23 …) about the definition of EI, the importance of EI in marketing and Kidwell’s paper. I also think that EI is essential in marketing
However, I would like to add a few points about the “cons” of EI that haven’t been mentioned. I believe these points are not “negative” but they are something worth…[Read more] -
rd389 replied to the topic Failure's of Pre-Clinical / Clinical Research in the forum Pre-clinical Device Development 7 years, 6 months ago
1. Why was a need to overdose animals?
2. What measures were taken to avoid future overdosing to animals?
3. How were the dead animals disposed?
4. Any care was taken during disposing, considering bio hazards?Sorry to reply to you guys (@ppp23 @scott) so late. So, I deal with the samples that are taken from these monkeys or other animals,…[Read more]