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 bia...

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,...

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. Wh...

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 devi...

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 cas...

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 th...

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 desi...

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 conduc...

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,...

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 ...

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...

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 ambigu...

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...

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 curr...

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 accide...