I would not start work without a written agreement. A verbal agreement can be misconstrued, and the details forgotten or tweaked along the way (increa...

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 ...

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 ...

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 thi...

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 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...

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 goo...

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. W...

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

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 p...

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 cha...

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 y...

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 worke...