The project proposal or project charter is the document approved by Management for a project to get underway. It actually will not usually include a ...

Now that we are 1 year in to this administration and the announcement to overhaul the FDA regulations, I thought this might be a interesting topic to ...

I have had the opportunity over the last 10 years to work with Drug-Eluting Coronary stents. These stents are delivered by a catheter, used to prop op...

Early on in the initiation and planning phases it is important to understand GMP requirements and how they relate to the project. For example, if you...

I work for Cordis, part of Cardinal Health and the organization is highly matrixed. I report to my supervisor within supplier quality and also serve ...

I have worked in the medical device industry for the last 14 years. The last 10 years have been at Cordis which recently became part of Cardinal Healt...