Risk management meetings in my opinion are the most successful with a great deal of varying backgrounds. When creating a risk document it is important to encompass all of the possible negative outcomes. For my company they are categorized by occurrence ad severity and then given a risk index from that point. The team is forced to try to list all…[Read more]

Validation in a way is an abbreviated version of the verification. It will allow the user to guarantee that the device or fixture is still functioning at its necessary caliber. It can begin with something as simple as checking the plug socket for correct voltage and become as detailed as making sure that ever FDA process is guaranteed to be…[Read more]

As you near the verification process the design review meetings become very important as they are a great opportunity for coworkers, management, or even document control to realize an issue in your verification before it is initiated. Once initiated and alteration of the verification severely increases the time frame for completion. The design…[Read more]

For a verification that I was recently working on we tried very hard to make sure the verification was written in a way that deviation could be avoided. We attempted to run the test ourselves as well as making sure that our product was perfectly configured and our test samples did not contain any errors. With this there is a still a large risk…[Read more]

I have been in many more meetings outside of the industry than I have meetings within the industry. In my fraternity we take very detailed minutes. Even though may seem this as unnecessary for a social organization but it is extremely helpful for event planning, and also returning to minutes to see whether a rule was established that someone is…[Read more]

Through my experience I have seen very few cases when a validation is not required. I believe a lot of the requirements come from internal pressure and may not be directly required by the FDA or ISO audits. When in doubt validate. It seems that you are in a way worse situation if a validation was not executed when it was needed than to validate a…[Read more]

I was lucky enough to have the opportunity to work on a Test Method validation that went into a design review. One thing I have noticed is that people will often make it seem like they have something to say even when they do not. I was not personally in the review but the engineer I was working under told me it can either be an extremely helpful…[Read more]

For a study to be considered to have followed the scientific method it must have an experimental and a control group. It is sad to know people are being told they are being treated but they are actually reviving no treatment at all. This is one of the risks you ensue when you agree to be part of an experimental drug study. The removal of the…[Read more]

I believe that if a clinical study is to occur the study should occur as a double blind study. Any bias that could alter the outcome of the study should be avoided at all cost. It is normal to want to trust the researchers or doctors to not tell the patient who is trial and who is control but their is still room for human error. A simple slip up…[Read more]

I understand that it is normal to worry about the life of another human being but it is a moment where the livelihood of the masses matters more than the individual. One thing that is not often mentioned is that the studies are voluntary. Due to the policies on correct treatment of patients the patient has to be aware of the risks of the study…[Read more]

Joining a partnership is very intimidating based on it is truly impossible to fully know someone until possibly when it is too late. When looking for a partner above all I think the most important thing to me would have to be honesty. Like relationship to a boyfriend or girlfriend if there is no trust the bond will break. Sadly, when it comes to a…[Read more]

I think this is an unbelievably interesting question to discuss. I do not I have ever looked into a company’s corporate structure, possibly due to a lack of knowledge on the subject, but I have definitely looked into the stock prices and income statements of companies I applied to. I believe a lot of the need for answers comes from the idea of j…[Read more]

I have assisted in an audit for the quality department and was honestly amazed in the company’s systematic ability to answer questions correctly and intelligently. The biggest lesson that I have learned from seeing an audit is to never give information unless it is asked. The quality department can give great information and documentation but t…[Read more]

I have to agree with julienneviuya. The idea that communication has to be constant is clear but also people sometimes fear consequences for being behind or not being able to do something that they will adjust the truth to make it seem like everything is going to plan. This departments begin to see themselves separate from one another losing the…[Read more]

The largest issue that I have seen in Document control is that there is an inconsistency in how documents are suppose to be completed. The established documentation practices document will give a great deal of guidelines for the other departments to follow, but they usually fail to completely encompass everything that needs to be done. This leaves…[Read more]

The manufacturing of a product should only be allowed if precision and accuracy are guaranteed. When some doctor or medical personnel goes to use a device they should be utterly sure that it is going to work exactly how they are expecting a device to work. Products are seen to have a huge mark up if you look at just the overhead cost of the…[Read more]

Any device that is going to be expected to help save and prolong human life should be strictly regulated. I believe people should have full confidence in anything they purchase that is expected to save their life. I also believe that more holistic medicines should be allowed to be marketed but not receive the FDA approval. I believe if a person…[Read more]

The Electronic cigarette industry should be looked at very similarly to the Nicotine Gum and Patch industry. They are attempting to assist in the quitting of all tobacco related product. One thing that has not been discussed is that there is a great deal of personal modification available to these vaporizing devices. Over powering or trying to…[Read more]

I believe the fulfillment of a successful long study must trump any feeling you can get from a short-term project. Which is why I always thought I wanted to do long term studies. When I was in high school I did a 6-month project on green tree frogs for 6 months. After 6 months, I found my results to be inconclusive. I can’t imagine donating my l…[Read more]

When I was in middle school I was in a debate on whether it was “good” to test on animals. At a young age, I saw how mean it was and decided that I was entirely against it. That there was other models and studies that could be used to replace these studies. As an adult, I have realized that its many cases it is extremely necessary to conduct the…[Read more]