The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or studies done by a contractor or collaborator…   Read more»

The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires additional evidence that can stand up in court. If there is any risk that legal…   Read more»

Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how it is really…   Read more»

It’s been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other projects. Sometimes, people with some expertise or knowledge necessary for the project are pulled in, regardless of their…   Read more»

My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. However, while there are projects that involve various departments, there are also projects within departments. There…   Read more»

The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design input and then critical development parameters were selected. A risk ranking was then…   Read more»

Two other methods are: Hazard Operability Analysis (HAZOP) – Based on a theory that assumes that risk events are caused by deviations from the design or operating intentions. It is a systematic brainstorming technique for identifying hazards using so-called guide…   Read more»

I’ve wondered about this as well, especially because in academic research I’ve needed to look at ISO standards and I wasn’t going to pay for them. I found this information given by ANSI: https://ansi.org/help/charge_standards.aspx. It seems it is really just…   Read more»

This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? I ask because typically for drugs and biologics, transfer to manufacturing is not done during phase I,…   Read more»

I can only speak to my experience, but generally it’s been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more just for documentation purposes. The team or project leader always sends out revised…   Read more»

If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characterization techniques that have been used to measure the critical quality attributes all through…   Read more»

I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required for production. It is usually larger companies that are producing many products that can justify and afford the…   Read more»

Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and/or scale than what will be used in manufacturing, the release specs may have to…   Read more»

It seems that the DHF is superior to the Design Dossier or Tech File in it’s thoroughness and documentation and that is why there seems to be a move in the EU toward the use of a DHF instead. From…   Read more»

I found a presentation that was put together by BioTechLogic to address this issue (http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/2016_CMCS_TreDenickTracy.pdf). It seems like it is a very involved process and I’ve just listed the major steps below: 1. Quality System Gap Assessment 2. CAPA 3….   Read more»

It’s important to add that when revisions are made to the design controls, change control procedures must be followed and documented. The FDA is very strict on this, since good documentation practices require that everything be documented or else it…   Read more»

I assume that sources of design input would be marketing studies on what type of product is needed, key opinion leaders, and scientific experts. In the lecture, Dr. Simon commented that marketing puts this together through customer opinions and development…   Read more»