Posted by: @hjp39 With the way everything is headed now, several departments have gone full time remote such as complaint handling, some regulatory positions, and even few Quality Engineer positions in my company. I am aware that this question may…   Read more»

Posted by: @hruship101 Many departments such as Manufacturing or R&D tends to complaint that their quality department is so stringent in terms of documentation and the document control even if it means to delay product launch or to prevent the…   Read more»

The areas that are important to me would be; The budget amount they are requesting. The budget break down. The price research and comparisons and the purpose for each expense that they are requesting funds for. Also find it interesting…   Read more»

The animal variety can influence the reproducibility of a pre-clinical research because the models are different. How a medication works in on animal may not work the same way in another animal. This is one the major challenges that pharmaceutical…   Read more»

Another great way to help is to put more funding into the development of alterative testing models. A great example would be organ on chips. This is a type of biotechnology they is able to replication human organ responses to…   Read more»

When considering the three types of organizations in project management I would prefer matrix organization. I choose this being in the form of organization because it is more hands on for those involved. You get a chance to see how…   Read more»

@tlstrickland Hey Tia, I really enjoyed your explanation on why matrix organization would be your preferred organization you would work under. What really stood out about what you said in your post that that when you have multiple bosses you…   Read more»

In case of an emergency certain medication and medical device for very rare disease can be used if they have not yet been approve but the patient must have exhausted all other forms of treatments. A physician and not used…   Read more»

@sfrancis  Hey Francis, Great post! Your choice of the three core competencies are really good picks. However, to effective use those skills do you think that a fourth skills might be necessary, such as communication skills. I state this one…   Read more»

@arianaburch  Hey Ariana, I really enjoyed reading your post and getting to see your view point on what skills you think a manager should possess. However, I want to challenge you to define more about what extacly communication skills are….   Read more»

If a device has been processed under a 510K then yes it would be considered a medical device. There are different classes of medical devices some be a simply as a medical band aid or medical tape are as advance…   Read more»

I work in a diagnostic lab testing mostly covid samples it is very impart we record different part of the process. A time that this was important was when a plate of samples was mislabeled on a PCR machine and…   Read more»

Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

Posted by: @devarshi-joshi After the development of team how do the execution process works or what does it do during the absence or vacation of an employee or with an personal problem? After the development of the team if a…   Read more»

Posted by: @mejefferson During the planning phase of project management, both time and money are crucial. Timewise, the longer your product takes to develop, the more money you will have to seek from investors yet your product will have a…   Read more»

Posted by: @ap962 The end of the Monitoring and Controlling Phase is marked by the Closing Phase. What are steps that need to be followed to ensure that phase is carried out effectively? Doing the closing phase it is important…   Read more»

Well if I was the project manager in this case I would have planned for 2 to 3 employees leaving during the course of this project. So, them taking a vacation should not effect the over all progression of the…   Read more»

@sfrancis  Francis, Great reply to the post. It is really amazing to see that you actual have real world experience with this. Because it is easy to give a test book answer to this problem to to actually have to…   Read more»

Quality assurance is the combination of administrative and procedural activities implemented in a quality system that are meant to ensure that a goal is completed are a project is fulfilled. While quality control is more so meant to serve as a…   Read more»