From my experience the quality assurance team performs tests on everything that comes in for product to ensure that the material meets it's specifications. They also test materials from vendors, and e...

As a PM, these types of scenarios should be anticipated with proper communication between all team members. As a result the project manager as the responsibility to organize and communicate between t...

Ussually when looking at vendors the company has a list of approved suppliers that would ease the purchasing aspect because prior business has already been initiated,and buying from an approved suppli...

Hi Fady, when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should t...

Well it depends, setbacks and delays often occur, but my question is, since this component is critical, does Arugalo Medical have a list of approved suppliers for this component and is this company th...

That a good question and it could be slightly trivial to answer. I believe that the original validation would not expire, but lets says there is a gap between the validation such as let's say that you...

I don't think missing a major milestone can particular effect future success of a product/project, delays should be anticipated and addressed in a timely fashion. Usually project managers incorporate ...

I agree the comments above, with the support of Dr. Simon's courses I feel that his courses provide a real world approach and look within industry. There have been countless of times were I refer back...

I agree with the comments above, I believe that the biggest difference would be dealing with the diverse regulations. From my previous experience within a cosmetic standpoint, I was working on a refor...

I had a similar experience, but with the purchase of a 2 identical pieces of equipment, but they were being placed at two different locations. We had to validate each piece of equipment, but with rega...

Hi Viraj, it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this...

Hi All, I was wondering if anyone knew of the concept of a Holistic Qualification/ Holistic Approach for Qualification, I know by definition it is done at the user site and it involves the entire inst...

Interesting topic, but is the balloon popping an isolated incident or does it happen all the time? I do agree that more time will be needed by R&D to address this issue, but is this product alread...

For my senior design project, we were working on a non-invasive vascular stiffness monitor, we were prototyping on bread board, which connected to a an ossciliscope for data analysis. Half way throug...

I have had a a few experiences in which completion of projects have been delayed, I was validated a new piece of lab equipment, during the validation process i ran into delays ranging from the acquisi...