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arianaburch replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 6 months ago
Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing… Read more»
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Justinjett replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 6 months ago
Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing… Read more»
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kc4310 replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 10 months ago
@alexandrabuga Great topic, a nice contrast to typical posts. I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate. You made some interesting points; I am ignorant to… Read more»
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llefevre replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 10 months ago
Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing… Read more»
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ajm73 replied to the topic "Overlapping activities" – 5 years, 10 months ago
@alexandrabuga I don’t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is… Read more»
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thuytienlecao replied to the topic "FDA Considering Updating Quality System Requirements" – 5 years, 10 months ago
Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law… Read more»
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thuytienlecao replied to the topic "Simulation 1: Faulty Quality System" – 5 years, 10 months ago
I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and… Read more»
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thuytienlecao replied to the topic "Marketing Strategy- The fifth 'P'" – 5 years, 10 months ago
I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to… Read more»
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ajm73 replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development 6 years ago
@alexandrabuga I don’t think that this is completely accurate. Depending on the company and how it is structured, sometimes employees wear many hats at once, being the critical members for many, many projects at the same time. This often is the case if there is only one or two people who are the subject matter experts on something and their…[Read more]
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thuytienlecao replied to the topic FDA Considering Updating Quality System Requirements in the forum Quality Systems Management 6 years, 12 months ago
Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don’t think QSR would be replaced…[Read more]
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thuytienlecao replied to the topic Simulation 1: Faulty Quality System in the forum Device Documentation 7 years, 1 month ago
I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document…[Read more]
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thuytienlecao replied to the topic Marketing Strategy- The fifth 'P' in the forum Introduction to Advanced Medical Device Development 7 years, 2 months ago
I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to social media and social networks, brands and companies can get feedback on where they…[Read more]
