Batch Failures: Significant Risk Events; Challenging Investigation Opportunities

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. Close to half of these included an observation about failure to thoroughly...
read more

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

The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) 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 that the information will be of value to those parties that are interested in which...
read more

A Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk

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 a chance to read a good book on a quiet beach somewhere. Unfortunately, for FDA-regulated companies, the FDA does not appear to be...
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 design;   assess and implement computer-based quality systems; and use process risk analysis to rationalize quality system decisions and improve inspection outcomes...
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 hunt for non-compliant companies, what can your company do about it? The short answer is be prepared! This webinar will...
read more