One key feature of post-launch product management is having a fully trained, knowledgeable, and enthusiastic sales force. It is important to keep a sa...

That raises a great question. From experience, I was on a project team where we were developing a cough and cold product for the market. At the star...

The above posts seem to discuss this well. It is very similar to this week’s simulation: assuming that a machine failed due to machine failure (or nea...

This brings up a great point- typically, engineers have limited exposure to technical writing. Personally, as an undergraduate, I was not required to ...

I would say that an alternative option to dual sourcing would be to also keep a “cushion” stock or back stock of both the final product and each compo...

It seems like one of the simplest and most cost effective ways to conduct post-market surveillance would be to request feedback from the patients usin...

Great question, Luisa. From previous experience, I, myself, have been responsible while working in the research phase to create SOP’s. This is impor...

Great question, Chris. I had a similar problem at a previous job when I was responsible for writing and updating SOP’s as well. One problem that I of...

I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts...

I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&am...

Syringe Filling Process IQ- Filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qua...

From my experience, your product will almost always require both a DHR and a DHF. The reason being is that one is for the design phase (DHF) and one i...

From my experience, the most post-market surveillance we would receive is from the end user, or the patient. People will often call the company’s main...