One example of what could shut down a clinical study is an adverse side effect, such as an allergic reaction. I’ve seen one clinical trial put on pause because one participant had a severe allergic reaction to the material being administered and it was thought that the whole group was at high risk but it ended up just being this one particular p…[Read more]

I’m not sure if clinical research would be the path for me either. I have some experience in creating clinical trial material and I did not enjoy it. It was very tedious and the amount of paperwork involved was enough to make your head spin. The other thing to take into account is the huge liability involved with a clinical trial, which puts a l…[Read more]

I’m not sure if cost would be the leading purpose for conducting a clinical study in a developing country but regulations and target audience would probably be. For example, a researcher interested in conducting a study focused around the ZIKA virus would be much better off in a South American country like Brazil, where the disease is much more p…[Read more]

One example of this that I have heard about has been thalidomide. Thalidomide was used to treat nausea and morning sickness in pregnant women in the 1950’s. Previous studies in mice showed that thalidomide was not a risk in mice, but it is in humans. It caused limb deformities/absence and phocomelia in the unborn babies and was withdrawn from t…[Read more]

Great question- I would have to say that if I were a sponsor, I would not want to transfer the responsibilities of: selecting monitors & investigators and overall managing/checking investigators. The reason why I selected these was because most of the other work that a sponsor is responsible for can usually be learned very quickly, such as record…[Read more]

From experience, I have seen GMP documents get updated fairly often and the reason for them being updated is usually because the previous instructions were unclear and created confusion. I have also seen GMP standards updated for technology updates, or building updates, such as a wash room being moved, and as a result, different tools were needed…[Read more]

Great question, neb2.

I’ve been a part of an internal audit once before and the main advantage that I saw as a result was that it introduced to everyone what an external audit would be like and it trained multiple employees on how to handle audit questions and answers. As Dr. Simon said in the lecture, external audits can carry on for quite s…[Read more]

I think that the previous answers work to describe the idea of CAPA well. It’s basically saying that you will not make the same mistake twice. If you know something is not functioning correctly or well and you continue to do it wrong, it would make sense the FDA (or governmental figure) would not be willing to overlook. In a way, it is a p…[Read more]

That’s an interesting question. I think that companies everywhere would be extremely happy to save the money, time, and hassle of going through GMP processes but ultimately, I think that something else would take its place that would not be required but make a company more competitive to have those standards. For example, similar to how the CE m…[Read more]

To me, it would make sense to grandfather old documentation into the new system, as it is. In my previous experience when Quality Systems were changed, it was required that all previous, in-process projects be updated to fit the new system. In hindsight, this seemed like the direction to go since it would save time later, but ultimately it did…[Read more]

From experience, I’ve found that GMP creates more arguments than anything else within a company and that is because of the ambiguity. The ambiguity lends itself to debate and people tend to get carried away with minor details. Discussions can carry on for hours as people debate whether a step in the process should be labeled as “may” or “shou…[Read more]

I agree with the above responses- R&D/Development phase seems to be the most expensive stage. The reason being that although one product may make it to the market and produce a great deal of profit for the company, there were many products similar to it, leading up to that point, that did not make it and cost the company a lot of money in time,…[Read more]

That’s a great question- I agree with your answer and thoughts on it. A big part of selling any item is the feel and confidence that you get when purchasing it but also the factual performance of the product or service itself. Were you provided with enough information to determine that the product in question will make your life easier or is it n…[Read more]

Hello,

While all are extremely important, I have found that the most important thing for a product manager to know would be to stay informed about the industry and market data. The reason why I say this is because it should also include knowing about competitor products as well as the aspects that affect product sales. In a way, it makes it hard…[Read more]

One key feature of post-launch product management is having a fully trained, knowledgeable, and enthusiastic sales force. It is important to keep a sale and advertising team up to date but also well-informed on the product because if a sales person cannot answer questions about the product, then the customer that they are trying to sell it to will…[Read more]

That raises a great question.

From experience, I was on a project team where we were developing a cough and cold product for the market. At the start of concept, the previous year’s data completely warranted entering the cough and cold market with an additional product; however, during the course of development, the cold and flu season was m…[Read more]

The above posts seem to discuss this well. It is very similar to this week’s simulation: assuming that a machine failed due to machine failure (or nearby machine malfunction), it would most likely not require a new IQ, OQ, PQ because the machine would most likely return to the functional condition when the parameters are changed back to the o…[Read more]

This brings up a great point- typically, engineers have limited exposure to technical writing. Personally, as an undergraduate, I was not required to take a technical writing course but it was integrated into many courses in the curriculum. However, even with the writing integration, writing required by industry, such as SOP’s, quality d…[Read more]

I would say that an alternative option to dual sourcing would be to also keep a “cushion” stock or back stock of both the final product and each component. This is often done at times in the industry. To ensure that this back stock does not expire and become a waste of money, it is continually replaced with the new stock product. For example, if…[Read more]