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 ...

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 differ...

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 wan...

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 documen...

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 sta...

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 ...

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 i...

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 founda...

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 ...

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 ...

@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...

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 b...

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 u...

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 t...

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 co...