Another method used is Expected Damage-Cost Analysis (EDCA). This method evaluates how often different hazards occur and ultimately estimates the dama...
At my company, we document user requirements in its own document. The user requirements also drive design input requirement and are linked via a trace...
From a professionalism stand point, I think the gantt chart and team expectations are important, but I believe the risk management deliverables and th...
I work for a company that manufactures handheld blood analyzers. In addition to the verifications performed to ensure the device reads samples within ...
In my experience, Supplier notification for custom components is extremely important for companies that outsource some of their components. At my comp...
I currently work in the industry but I’ve had little experience creating and managing Gantt charts. One issue that I face EVERY TIME I make a chart is...
Of course in the medical device industry they say “if its not documented, it didn’t happen.” So capturing decisions made and the logic behind the scop...
Similar to some posts above, I would also like to be an investigator. It seems like they are directly involved in the meat a potatoes of the trail. Bu...
According to Johns Hopkins, in the 1950’s the practice of obtaining informed consent from cell or tissue donors was essentially unknown among academic...
I agree with the posts above that placebo trials are needed. However, the experiment design must be controlled in a way such that ethical concerns are...
According to LegalZoom, if the sons must create a new business since a sole proprietorship is non-transferable. Once the original sole proprietor dies...
I read this article about how a company was ready to go public and I thought it was interesting. From what I understand going public must be a timely ...
Abbott Laboratories reported revenues of $6.64 billion in 2Q17, exceeding the analysts’ estimates. Abbott stock gained more than 4% the day of its 2Q1...
Based on my experiences in the industry, the risk to quality isn’t because of incompetence or neglect. I believe it is mostly because of the pressures...
I have not participated in an audit from an audit stand point but I recently attended a weeklong training on the FDA’s Quality System Regulation by AA...