POPULAR SCIENCE; BAD JOURNALISM

Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a company’s characterization of what can best be considered a sham product as a... Read more

FDA Warning Letters Increase 155% from 2010 Levels

If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement activities since 2008.  Alternatively, if you are involved at all with supply chain,... 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

UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad

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

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