After going through the lecture and reading Dr. Simon’s post, i became curious. What if there were no GMPs? For example, what if you had a choice between GMP or no GMP. What would you do with this option? What…   Read more»

As we learned the Project Management processes over the past few lectures: Initiating Processes, Planning Processes, Executing Processes, Closing Processing Each process was very well defined and given certain inputs/outputs and what is done during each phase. My question for…   Read more»

As we do this week’s simulation, we see that it requires the team members to use their Interpersonal skills to make a deal as well as the background information and business knowledge to make the best deal. My question to…   Read more»

As this week’s lecture talks about “killing a project” or “go” with the project. As mentioned in the notes, you would typically “GO” with a project if marketplace is attractive, concept aligns with corporate strategy, and resources are available. My…   Read more»

I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced? I personally have benefited a lot from taking Dr….   Read more»

Looking at this week’s simulation, if you were the customer Arugalo Medical how would you modify your timeline if the component you need from a vendor will be delayed for an unknown time period. Since it is critical component what…   Read more»

Hi Guys, So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course? My personal experience, I…   Read more»

According to the lectures, Process Validation according to the FDA is defined as “results of a process cannot be fully verified by subsequent inspection and test.” And process validation according to ISO is defined as “processes for production and service…   Read more»

As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your device or product to go…   Read more»

As Dr. Simon discussed in the lecture of how the Work Breakdown Structure (WBS) can be broken down. There is isn’t one way of doing this. WBS do not have to be a certain way. They can be broken down…   Read more»

This week Dr. Simon required us to work in a team and solve a problem using our knowledge, research, and other skills. I had the pleasure of working with a great team and everyone has been on point in achieving…   Read more»

Hey guys, After going through the notes and google, I wasn’t really able to tell the difference between a Device history file and device history record. For anyone who has experience in the industry, when do you need to generate…   Read more»