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

New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?

The new Inspections Database ( is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement actions and results across the country and rest of world. It is certain... 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