Smile, You’re On FDA-Camera!

The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections, in light of FDA's new, final "Guidance for Industry on Circumstances That Constitute... Read more

CAPA – The Untold Story

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

Webinar, June 23: Inspection Readiness for a More Aggressive FDA

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

Interview: FDA Inspection Readiness

  Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS   March 2010 What are the biggest issues currently facing FDA-regulated companies when it comes to FDA inspections? FDA regulated companies are currently dealing with a multitude... Read more