I agree with previous comments about the DHF being a living document. I would like to add on the previous ideas about the advantageous of it being a living document. 1. Being a living document, DHF wi...

I would like to add some points about shutting down/pausing studies. It doesn't take much to make it happen. The IRB has a lot of power in this matter. My lab was in a "pause" mode for a few weeks and...

I would like to answer the original question and add the points about general clinical trials without the animal studies that have not been mentioned. "how can you possibly predict that beforehand"? w...

At the lab where I used to work, we had both prospective clinical study which is collecting data in real time or retrospective which is using old data to be analyzed. The way the studies were organize...

I think I actually have a different opinion with you guys. I worked in clinical research for at least 2-3 years in a hospital in NJ and I wouldn't mind working in clinical trials, maybe as a study coo...

Thanks, @merzkrashed. Then, is it recommended to internal audit themselves and then hire an auditor?

@gh56 and @merzkrashed had talked about the 3 basic concepts of QM principles: system approach, process approach, and factual approach. I would like to add on some other principles that I think are al...

hi guys, I am a bit confused about internal audit, if anyone knows, could you please clarify? In the lecture, (slide 9), it's stated that for internal audit the company performed by itself and it's n...

I agree with previous comments about Correction being the short-term solution and Corrective action, on the other hand, is a long-term solution. Correction is taken to rectify a known nonconformance a...

Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 8...

I agree with previous comments about internal audits and would like to sum up and expand the pros and cons for this type of audits. PROS 1. It helps compare your practices and processes against propos...

I believe the above comments are solutions from the business/company admin side. To answer Fady's question from the employee perspective, I believe the best way to communicate to management that addit...

Thank you for an interesting question with a lot of different views. In this unforeseeable situation, it's difficult to say "to kill" or "not to kill", it's a case by case basis. And if it is "to kill...

I agree with previous posts about funding being the key driving force to support change and innovation. I would like to add in the timing factor and market condition. A lot of time, a deadline is a st...

There are three primary types of obsolescence: technical obsolescence (new technology surpasses the existing technology), functional obsolescence (when a technology can no longer be fixed//upgraded du...