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 st...

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 bene...

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...

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 classific...

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 exten...

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 s...

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 ...

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 ...

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 ...

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. Fo...

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...

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 bel...

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 introduct...

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...

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 pe...