I would choose matrix for a medical device company because it is flexible to pick members for the project without having to fully remove them from throt positions. The employees must report everyday to the manager and this allows for the manager to know what is going on everyday. Matrix organization is also have good management of resources, no…[Read more]

It would be ideal to work in a team where the members are knowledgeable in their department role and I have a good relationship with. When you have this combo, it is a setup for success. When you have someone who is good at their job but doesn’t get along with everyone, it makes it really hard to be on the same page and get the work done. But…[Read more]

I think I would be best suited for the middle management because I can be a manager and delegate on the project work but I will also still be responsible for some technical work to get done for the project. But if i was working for the top management, I would be responsible for all the work that I am delegating and that means having to pick the…[Read more]

For both the companies I interned at, had me sign non compete agreements. I had to agree that I would not work at a competing company for at least a year I was done interning with this company. This was not an issue for me since I had worked during the summer for both companies and I had a year break. But I do remember a co-worker who had gotten…[Read more]

For me personally, written agreements are better because it is set in stone and nothing can be forgotten. If a verbal agreement is made, some of the things maybe forgotten by one or all members of the agreement. Projects can be started from verbal agreements but when having a written agreement, the project can be more successful since everything…[Read more]

The restrictions that the gifts have to be less than $100 and have to be educational is a bit restricted I believe. I agree with the fact that the gifts should be educational but putting a number on how much you can spend makes it hard to find the perfect gift for the physician. We are gifting the physicians for the work they are doing and for…[Read more]

Regulations are very important to any company because the products have to follow a certain standard for safety. Some people may argue that it is unfair but the FDA does a really good job to ensure the standards are followed and they should be paid to make sure this is done properly. All documentation should be paid if not, anyone can access it…[Read more]

I never had the chance to sit down in a risk management meeting but as working as quality intern, I did have a chance to read an FMEA. They are very very long and there are numerous revisions. Each new revision is longer than the previous due the new risks the team has come up with. But if you have the chance to read an FMEA, you can see the…[Read more]

To change the way we think about risk, we must avoid making six mistakes.

1. We think we can manage risk by predicting extreme events.
2. We are convinced that studying the past will help us manage risk.
3. We don’t listen to advice about what we shouldn’t do.
4. We assume that risk can be measured by standard deviation.
5. We don’t appre…[Read more]

When the design controls are not proper, it may cause the project to be set back because the product can not be cleared unless everything is correct. Design controls are in place to have the product design properly so that there will be no mistakes. Also if the design controls are not sufficient, and there is an audit by the FDA, this will not be…[Read more]

Gantt charts are very important to the project because it highlights the milestones for the project. The critical path is crucial because it ensures the project is running on time and there will be no issues when moving onto the next milestone. The critical path makes sure there will be no deviations. When deadlines are missed, it sets the…[Read more]

Design reviews are very important in the success of the product and the company. I have had the pleasure of sitting in a design review meeting in my past internship. The project manager and the engineers involved in the project come to the meeting and review the past and present actions and any complaints or issues that have showed up since the…[Read more]

Basically what the FDA looks for when they do an audit is to ensure all the documentation is proper and all the protocols are being followed properly. The FDA will try to find anything to mark down. They are not doing to harm the company but only to improve it. The FDA wants to make sure there are no hazards and no shortcuts are being taken to…[Read more]

A DHF is a design history file which is a formal document that is prepared for each document. The DHF contains all the documents needs to produce the product. It contains all the design stuff along design review meetings and every small thing required. It should contain all the SOP’s required for it and all the documents should have the current…[Read more]

Minutes for meetings are very crucial to a company because it keeps track of everything and what everyone said. We go to many meetings every week and sometime we have more than one meeting a day also. We can not possibly remember every single detail from each meeting so it is good to have document to read what took place in the meeting. From my…[Read more]

Placebo controlled trials are needed for clinical trials and they are ethical. As humans, we tend to overthink and overanalyze situations when it is not needed. Most of the placebo trials are done because we feel that medication will help us when we take the pill. For instance, if we are told we will be given a pill that is supposed to make us…[Read more]

I think I would like the role of Clinical Quality Assurance Auditor(CQA). Any clinical trial will have a lot of paperwork from the consent forms to the update of the procedure. This might be a tedious job but I believe it is one of the most important ones. If there is misinformation about anything, it can cause that certain results to be thrown…[Read more]

I agree with the points the above students have stated. Clinical trials are done because doctors are trying to improve science and medication. There are many ways to test if a medication or a procedure will work but in certain cases, the only way to know if it works is through clinical trials. Doctors will have myriads of research about the…[Read more]

The four P’s are undoubtedly all equally important. This strategy is a business tool used by a company to produce a desired response from its target market and it consists of everything a company can do to promote demands for the product. These four P’s are very simple to understand—the Product is the goods offered by the company to its custo…[Read more]