we are at almost the end of the finishline, we get through the DID, DDP and the risk management plan, only thing left is to come up with a clinical protocol for the clinical study. The challenge that we face…   Read more»

my current job is at a company that would be considered as a matrix organization. there is a chance to move from one group to the other, cross train of many different things and get involved in different projects. being…   Read more»

with higher management roles it comes way more responsibilities that one might get overwhelmed with. Higher the managers position in the organization the more people they are incharged of. I would want to be working in the middle management role,…   Read more»

A risk management file is where you would keep all the documents and files that are in regards to risk management of projects. Everything should be documented on the risk management file. this document is more like a living document…   Read more»

I have not personally participated in the FMEA process, but normally in my company that works on the biologics FMEA process happens under upper management supervision. However, the process of FMEA starts with my team getting together in a group…   Read more»

I can’t decide which one I would go with over the other, mitigation or acceptance. While mitigation could be the most effective way to save money and to mitigate around risks, in certain examples you could get away with just…   Read more»

Verification is laying down the foundation of the validation. Verification makes sure the product works the product works the way it is supposed to. Validation test how well the product works and it is required to demonstrate tests on devices…   Read more»

I agree with some of my classmates’ opinions, I don’t think I would say one part of the DDP is more important than the other. All the information provided in the DDP provides a well-established foundation to execute the project….   Read more»

in research and production having document control is very essential. For example, if new people were added to the team and wanted to learn more about the project and its progress, they would be able to look back and see…   Read more»

If you asked me before working for corporate I would probably say meeting minutes are just repetitive and there is no point for them if you already attended the meeting. However, they play such a big role in referencing certain…   Read more»

@sts27 I agree, in my opinion, I do think in academia different departments have different regulations. For example, I do believe the life sciences department could have different regulations than the engineering department. An example of regulation needed for engineering…   Read more»

Verification protocol is very essential to demonstrate the safety of the device on the user. an example would of a product that needs verification protocol before it is allowed for the public to use be the covid 19 vaccines. this…   Read more»

I disagree, pharmaceutical drugs can be used to cure certain diseases. those clinical trials are very essential to test the effectiveness of the drug. for example, medications that are heavily being used nowadays to help treat coronavirus have had great…   Read more»

the need of a clinical foundation relies upon the job that one chooses to follow. I would state that jobs in clinical research require a clinical foundation due to the job requirement to execute the tasks needed. This is an…   Read more»

Clinical trials are essential for testing new drugs, devices, and vaccines in development. People have signed up over many years to be subject of the test in clinical trials. While I understand the concern of the side effects that the…   Read more»

that’s a tricky question, emotional intelligence could be manipulative if the sales rep isn’t honest or looking out for the consumers’ benefit. a successful sales rep knows how to provide the right consumer for the product with all the facts…   Read more»

I agree with @sallirab, for a successful project, the product manager and the sales rep have to be in sync and have proper communication. These two roles play the most important role in developing the product. the project manager is…   Read more»

A successful project manager would make sure to include the sales rep from the beginning of the product planning phase because the sales rep would have a better idea of the consumers needs. it helps the company connects well with…   Read more»

that depends, do I know the person I am going to have this partnership with? there are plenty of failed partnerships where one could lose everything they invested and the other partner would remain unaffected. Having a partner ideally would…   Read more»

that’s an interesting topic to be brought up, I do believe I would accept or reject a job based on the company and the company reputation even if it means I would struggle to find for a bit, but at…   Read more»