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 later and contradict what they originally agreed…   Read more»

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 article I read several years…   Read more»

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 not navigated through this regulatory pathway before….   Read more»

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 however I am…   Read more»

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 depending on product…   Read more»

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 with little to no…   Read more»

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 more benefit where the alternative is…   Read more»

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 format to list all…   Read more»

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 mitigate risks observed with processed non conforming products. We also use…   Read more»

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 bringing to market product B…   Read more»

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 is, at my company the flipping of…   Read more»

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 at meeting minutes has been helpful in…   Read more»

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 ambitious timeline with little to no…   Read more»

I actually didn’t know this law existed! At a glance it sounds like a good thing. For terminally ill patients this could provide a sliver of hope or a chance for them to contribute to science. Given my limited knowledge…   Read more»

The original post mentions that “Placebo is better than no treatment” however I believe placebo means no treatment is actually given. For example a placebo for an injectable drug could be a saline injection.  I do see the ethical dilemmas…   Read more»

My opinion is that humans have a right to decide what they want to do with their body including whatever is removed during a surgery. Some people do not want their tissues/specimen to be part of research and  to me…   Read more»

One example in particular came to mind when I thought about manipulation in sales. Apple recently launched their new iPhone 12 phones and are not including the wall charger and earbuds which they say is a more environmentally friendly approach….   Read more»

Colors can influence your feelings and actions. If you see red you might think danger or stop, green could be positive and encouraging. I found a chart of different colors, words associated with them, and what companies use these colors:…   Read more»