I would not start work without a written agreement. A verbal agreement can be misconstrued, and the details forgotten or tweaked along the way (increase in scope). One person can change their mind lat...

I do believe these restrictions are necessary. As many have mentioned before, greed can become a problem and the money can maybe cloud the judgements of some. One thing that comes to mind is an articl...

The company I work for works mainly with HCT/Ps which are regulated less stringently than medical devices by the FDA. For one particular project, the product was a biologic however this company had no...

The company I work for currently has a functional structure but we are starting to transition into a matrix structure. We are at the beginnings of this so I haven't experienced much of a change so far...

The way I have seen the company I work for put together a project team is by taking into consideration area of expertise and workload. At the company I work for we are divided into different segments ...

I had not considered myself to do more management roles since I prefer the technical side of things. However I have been exploring the idea lately. To echo what everyone else has said, as a person wit...

Hi Everyone, FMEA documents can be very lengthy and tedious to review. Often times I find it difficult to start. I attended an FMEA training last year where they recommended to gather all the key mem...

A risk benefit analysis can be done to determine whether the risk outweighs the overall benefit to the patient. As mentioned above, vaccines are a good example since the overall immunity you get has m...

In my experience we tend to use FMEAs more. We use them as described by Dr. Simon in his lectures and also for determining risk in non-conformances. When we have process deviations we use the FMEA for...

I have also used reliability and confidence to determine sample sizes for testing during validations. I have also used AQL (acceptable quality limits) sampling when doing additional testing to mitigat...

An example I have encountered on when validation wouldn't be required is related to product packaging. At the company I work for we have a validated product A with packaging A. We are working on bring...

The change control process should identify everything that the change would impact and create an action plan for how to address the results of the changes. An example of an inadequately planned change...

I agree with everyone that keeping meeting minutes is super important. It gives you something to reference in the event that you missed something in your personal notes. I know personally looking back...

There are different types of validations that can be performed. I have done packaging stability validations, product stability validations, and shipping configuration validations. Below is a brief des...

From my experience in industry I would echo everyone who has said that you need to consider delays/setbacks and build that into your timeline. I worked on one particular project that had a very ambiti...