The design controls that could potentially be visited do include DID, DDP, DSD, verification/validation protocols, risk analysis, and risk management. However, since this is a homeopathic product, the...

From my experience, the initiation process can be divided into 4 phases for project management: Objectives: The first phase involves creating an objective(s). This is where you determine what informat...

I have an example I can share based on the definition you give. Take a smartphone for example, focusing mainly on the touch-screen interface. Validation processes would involve making sure that the pr...

I believe the two positions are quite similar in a lot of ways. I see the clinical pm as a subset of project managers as a whole. According to progenics pharmaceuticals, these are the primary responsi...

Going of la82's post, I think the way the FDA defines the line between a device of significant and non-significant risk is blurry. I think this guideline especially raises a few concerns: • Otherwise ...

As Dr. Simon pointed out in his first video, it is important to understand the history of the FDA when learning about regulation. One event I would like to highlight is the thalidomide scandal of 1962...

I have not worked in industry before, nor do I have experience in any type of the organizations listed. If I were to go into industry, I would feel more gravitated towards a project-based organization...

I agree with the all the skills that Dr. Simon mentioned in the lecture, and I would like to add another important skill a project manager to possess. This skill can fall under awareness, but I believ...

Design Validation is the assurance that the product is able to meet the needs of the customer and is in accordance with expectations set by the engineers responsible for creating the product. It invol...