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 will be updated after…   Read more»

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…   Read more»

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”? we don’t. There can always be an unforeseeable…   Read more»

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 organized were so that…   Read more»

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 coordinator or…   Read more»

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 also important: 1. Customer focus: it emphasizes…   Read more»

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 not as serious. My question…   Read more»

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 and Corrective Action is taken to prevent recurrence of said…   Read more»

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 820 QSR is the law…   Read more»

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 proposed prodecures and make corrections…   Read more»

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 additional resources are needed is to speak up management have…   Read more»

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…   Read more»

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 strong driving force…   Read more»

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 due to parts or software compatibility) and planned obsolescence (a business strategy used to increase…   Read more»

I would like to add that it would be very costly to re-validate everything. Imagine there is mass production. This “critical machine” might have produced thousands of products if not more. I agree with most of you about the decision…   Read more»

Hi, I agree with most of you about the fact that the device needs to be validated again once it’s moved because you don’t know what could have changed during the process.But depends on the condition, you may not need…   Read more»

Some critical-process standards include a requirement for re-validation at “defined intervals”, and to require that those “intervals shall be justified”. (Language of ISO 11135-1, EtO Sterilization.) It is common in the US device industry to regard the outer limit for…   Read more»

I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not…   Read more»

I have never worked in the industry. With my very limited related experience, I think the best set up of QMS depends on the size and function of the company.If the company is very small, it’s ineffective to have such…   Read more»