Hi mjf34, That is a really interesting example. I have always wondered what the negative outcome would be of attempting to complete a double blind study. However your example of the group becoming bias based on the experimental group and…   Read more»

Hi All, I would agree that both MDD and AMDD are very useful and practical classes. Working in the pharmaceutical industry, I even saw the great benefit. I believe that these courses, or similar ones, should be a mandate for…   Read more»

Hi All, The thoughts above were great, and I would have to agree that I have learned much from the simulations. One of the main things was simply how to better work with a team in solving problems. While I…   Read more»

Hi All, I would agree with the examples and the points given above. I believe that SR vs. NSR is really determined by a combination of the classification of the device and the application of the device. As was mentioned…   Read more»

Hi All, I found that interesting as well. I believe the partial answer to your question is that there are unexpected results sometimes, even if extensive animal trials have been done. There can be cases where we would expect certain…   Read more»

Hi All, This is a very good question. I actually work with a company that helps Pharmaceutical companies to connect with CROs and I found it quite surprising how much they are willing to outsource through these companies. Many of…   Read more»

Hi All, I would agree with the many point above made about CAPA. Since first learning about I can truly see why it is needed in companies to repair non-conforming products. It is really a system designed to prevent and…   Read more»

Hi All, I would agree with the points made above and believe that they highlight the main pros and cons. I would also agree that it is largely up to the company to decide how they would like to conduct…   Read more»

Hi All, Thank you very much for your input on this question. I would agree that when a company’s technologies are updated the GMPs must then be kept up to date. When these updates in technology occur, they can drastically…   Read more»

Hi All, I think the best way to make this change is to grandfather in some projects, but making a specific completion percentage for the projects. For example if a DHF is complete and Design Transfer is complete then the…   Read more»

Hi All, This is a very interesting question about the GMP process. I believe that if all companies had the choice between GMP and no GMP, there would be those that choose no GMP. These companies would be able to…   Read more»

Hi All, Yes, I believe that the ambiguity of GMP’s make it difficult for start-up companies that do not have pre-existing GMPs; however I do not believe it simply sets them up for failure. The ambiguity of the GMPs allow…   Read more»

Hi All, I would agree that in many products the R&D/Development can be very expensive. However I would say with many products that the introduction phase can be just as costly. If a product needs a lot of marketing to…   Read more»

Hi All, Thank you for the question as well as the comments so far. I believe that, as stated above, both interpersonal skills and business skills are needed to close a deal. To give an example, I currently have a…   Read more»

Hi All, I have not had personal experience with a product recall; however one I remember quite well is the Toyota recall of many of its cars. The pedals had the tendency to stick, causing many accidents. Over 4.1 million…   Read more»

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 I believe is often overlooked, but still extremely important is the creating…   Read more»

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 the most sense for a company to kill a project if it will…   Read more»

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 market and the evaluation of the market. Ensuring that the market is a…   Read more»

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 on a machine it would need to be re-validated. However if no changes were…   Read more»

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 industry, with very little done in medical devices. However taking these courses, I…   Read more»