The first thing that I would do is identify what issues are currently being faced. In this case, the product was clumping and the CMC was leaking out. With that identified, small fixes would be the ne...

I agree with ec52. When you assume you know everything, you tend to make mistakes. Consulting someone who is an expert in the area of interest can be a tremendous help with scheduling. The Subject Mat...

Maybe I worded the original post poorly. Yes, violating the current standards can be dangerous to the end user & costly to the company. As more regulations are developed, making medical devices b...

Logging the work that you do is extremely important. An example of this is a recent event at my current workplace. The telemetry system had gone down and I was called in to repair it. This just so ha...

Overcommunication, to me, mirrors micromanaging. Being consistently on top of someone to the point of pestering them.

Establish a communication protocol at the first team meeting. Communication is the most important aspect of teamwork, in my opinion. Being fair and appropriate to everyone's preferred method of commun...

This would depend on the timeline as a whole. How much time has been allocated to this segment in the project? Were there any milestones missed prior to this that have already delayed the project? The...

What I would recommend is falling back on policies and procedures. At my current job, there is a policy surrounding PTO(Paid Time Off). We have to submit a request a minimum 2 weeks prior to the date ...

The first problem that came to mind is communication. A PM has to communicate effectively to their team, investors and clients (to name a few). They should set up a reliable communication system for e...

Missing a Milestone is bad, however, should not be deadly to a project. A well-designed project will have some wiggle room in case of tasks not going as expected. A missed milestone may also set you b...

It may seem straightforward to you, however, there are cases where companies are not following regulations. A recent example would be Philips Healthcare. They were forced to cease operations at both t...

Risk Management has some requirements stated in ISO 14971. Dr. Simon stated that he would have it done even if there were no laws surrounding it. Is there any other ISO requirements when it comes to d...

During the planning process, inputs are taken from the customer. Those that have worked in the industry, what is the most unreasonable input request you have received from a customer? How did you hand...

In the presentation this week Dr. Simon touched upon Risk Management Teams. Specifically, he spoke about the Risk Management Team can either be the same as the Project Management Team or a completely ...

The classes defined by the FDA are Class I, II & III. Each company may label them however they want internally. Companies tend to give the projects pseudo/ temporary names while the product is sti...