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Two FDA Quality Systems Compliance Resources Published

Two new FDA quality systems compliance resources – "Bulletproof Yourself against FDA Enforcement" and "FDA Quality Systems Records Requirements for GLPs, GCPs, GMPs" – have been published by the SmarterCompliance™ newsletter and Cerulean Associates LLC.

Williamsburg, VA, February 22, 2009 --( Cerulean Associates announces the publication of two new resource kits for pharmaceutical, biotechnology and medical device firms dealing with FDA regulatory compliance. Both publications combine recorded executive teleseminars with resource kits of checklists, templates, example FDA warning letters, and other reference material designed to ease implementation of various recommendations and expert advice.

Bulletproof Yourself against FDA Enforcement builds on Cerulean’s in-depth industry report from last year, FDA Enforcement Trends 2008-2009, and adds a review of the top 10 agency inspection priorities for domestic US and international sites, four detailed self-assessment checklists, a step-by-step strategy for ensuring positive inspection outcomes, three article reprints, and an hour-long audio-visual analysis of the FDA priorities for 2009 along with recommendations to stay off the FDA radar screen for the next 12-18 months. Also included is a complimentary copy of the industry report, FDA Enforcement Trends 2008-2009.

FDA Quality Systems Records Requirements includes a 9-page matrix of FDA records and documentation requirements for firms during GLPs, GCPs, and GMPs, an 11-step strategy overview guide, several self-assessment checklists, a policy framework template, multiple article reprints, and other reference materials. Also included is an hour-length audio-visual recording of last week’s executive teleconference with questions and answers from the audience.

Both resource kit publications are available – either in download format or CD and hard copy – through the Cerulean website at

Cerulean's next online seminar for executives, Frugal FDA Compliance: Getting More Done with Less, is scheduled for Tuesday, March 24. Want to attend? Visit to learn more and register.

John Avellanet is the founder of the regulatory intelligence and lean FDA compliance program for executives and business owners, SmarterCompliance™. He is the author of more than 30 articles on lean compliance and FDA quality systems, a contributing author to the book Best Practices in Biotechnology Business Development (Logos Press), the publisher of the SmarterCompliance™ newsletter, and a frequent speaker at industry conferences.

Cerulean Associates LLC is a private advisory company that helps executives in the pharmaceutical, biotech and device sectors cut costs, streamline quality systems, speed new drug, biologic or device time to market, and protect their intellectual property from theft. Cerulean publishes the SmarterCompliance™ newsletter as part of its SmarterCompliance FDA executive advisory program. On the web at

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Cerulean Associates LLC
John Avellanet

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