Although Corporate America has embraced the concept of metrics and dashboards for close to 20 years now, the US Food and Drug Administration (FDA) has only recently come to the conclusion that incorporating a review of company-provided product quality metrics... Read more
I had an interesting phone call today with a company named ZenDoc — www.getzendoc.com — a software company, headquartered in Dublin, Ireland. The company contacted me to introduce me to their "new" document management software that in their words,... Read more
Today's (4/25/2012) news from In-Pharmatechnologist.com (see full link below) highlights information from FDA's 2011 Warning Letter dataset. The article states that: "In fiscal 2011 the US Food and Drug Administration (FDA) sent biopharma manufacturing-related warning letters to 52 facilities.... Read more
August… Summer... Sun, sand and surf... As the song goes: “summertime and the living is easy…” My hope is that all of you involved in quality and compliance are enjoying some time off with friends and/or family and getting... Read more
Try as I might in my consulting work, I can never seem to get away from CAPA. As much as I would like to help companies prospectively improve their process control; embrace better quality system integration and document... Read more
This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the IPhone OS4. This update to the Apple IPhone operating system added great new... Read more
Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA. Now that pharmaceutical, medical device, dietary supplement, and biologics' companies know that the FDA is back on the... Read more
Aren't the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips! As Quality & Compliance professionals, we often need to reference a section or two in the regulations. ... Read more
