In the Discovery and Innovation phase of the Product Life cycle phase, it is important to understand the customer. Analyze and research the customers ...

As others have mentioned the main reason a product gets "killed" midway through the research phase is simply due to the money. If the research and dev...

I don't have experience with dealing with a launched product that failed, but the most recent example of a product having to be pulled from the market...

The purpose of the SOP is to create a step by step procedure to help workers carry out routine operations. So, I don't believe that there is any issue...

I believe SOPs are required for the research phase, because there should be steps on the thought process of you reaching that idea, exploring the diff...

As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the val...

I don't believe there is really an expiration date for a validation. Each installation qualification process gets updated every year or so. Due to thi...

Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and i...

Along with having multiple vendors, as a Manager you should also account for the risks that a potential vendor may run into issues. With this you sche...

If equipment gets moved from one location to another, I do agree that a revalidation would have to occur, but for only certain aspects. There are many...

For the antibiotic releasing hip stem manufacturing line which creates an artificial hip with an antibiotic coating on the surface, I believe the IQ i...

ECO's are not very commonly used once the device is on market due to the main reason of money. However, recently at my company the on market device wh...

Per personal experience to track the medical devices while it is on market, the company I work at has a technical support team that answers any immedi...

To answer your question of when do you need to generate a DHF vs. DHR is that the DHF is created during the first planning session of the developing t...