Hi All, I would agree with the comments above that each role is important and it is difficult to say which would be most important. However, one that...

Hi All, Thank you very much for your interesting question, I had not thought about this instance in the past. However I believe that it would make th...

Hi All, I was thinking about the Planning and Development phase of the Product Life Cycle. One of the most important aspect in this phase is the mark...

Hi All, This is a very interesting question that I had not thought about before. As was mentioned above if any changes, upgrades, or repairs occur o...

Hi All, Thank you for the great question. I feel these classes have greatly benefited me as well. I work mainly in the pharmaceutical side of the in...

Hi All, I would agree that this simulation really shows the importance of having multiple vendors. It will limit delays like this and allows you to ...

Hi All, I do not have personal experience in this area however I could see why the quality team would argue that when equipment is moved all process...

Hi All, I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verifica...

Hi All, After viewing the lecture for this week, I have thought about the IQ, OQ, and PQ for the Syringe Filling Process – filling syringes with an i...

Hi All, I would agree with those that stated the SOPs should contain as much information as possible. As soon as something is left up for interpreta...

Hi All, I would agree with those that stated SOPs should be required during the research phase. Working for a start-up we did not have many SOPs in p...

Hi All, My best understanding is that the Design History File (DHF) contains all information about the development of the the product, as the design...

Hi All, Post Market Surveillance is simply the process of monitoring a device after it is part of the market. It includes many aspects of a medical ...

Hi All, Thank you very much for this interesting topic. I have not worked too much with ECOs; however I do have a bit of experience. I have needed a...