FDA Supplier Management Conference Chaired by Cerulean's John Avellanet

Cerulean's John Avellanet will chair a three-day conference of FDA officials and industry veterans discussing key regulatory requirements and industry best practices for managing suppliers and conducting supplier qualification. - August 05, 2011

Speed New Drug and Medical Device Time to Market with Advice in New Book by Cerulean's Managing Director

Speed New Drug and Medical Device Time to Market with Advice in New Book by Cerulean's Managing Director

FDA compliance guru, John Avellanet, shows biopharmaceutical and device executives how to speed time to market with new medicines and turn regulatory compliance into a competitive business advantage in his new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine. - February 19, 2010

FDA Medical Device Experts on How to Avoid FDA and Courtroom Troubles

Two FDA compliance experts will offer an executive workshop on how to ensure your internal company documents actually reflect your company’s commitment to product quality and patient safety, and the policies you’ll need to meet FDA requirements and reduce your risk in a lawsuit. - September 20, 2009

Cerulean’s John Avellanet Interviewed on 21 CFR Part 11, Computer Validation, and His SmarterCompliance FDA Advisory Program in GxP Lifeline

Independent FDA compliance expert, John Avellanet, was recently interviewed on how companies can save money by taking advantage of where the FDA is headed on 21 CFR Part 11 and computer virtualization. - March 20, 2009

FDA Regulatory Agenda for 2009 Matches Forecast by Cerulean Associates LLC

The FDA's CDER released its 2009 agenda last week, most of which mirrored many of the 40+ recommendations published by Cerulean Associates in its December 2008 SmarterCompliance newsletter. - March 02, 2009

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. - February 22, 2009

Pharmaceutical Processing Magazine Cover Features Cerulean’s 2009 FDA Forecast Under the Obama Administration

Under the Democratic Congress and the Obama administration, the US Food and Drug Administration will take an increasingly tougher line with pharmaceutical, biotech and medical device executives; this according to a new analysis published last week in Pharmaceutical Processing magazine. - January 29, 2009

FDA Advice for 2009 Published by Lean Compliance Expert and Cerulean Associates

2009 will be a year of transition for the FDA, with new leadership and renewed Congressional scrutiny, resulting in an agency eager to prove its mettle and toughness on the pharmaceutical, biotech and medical device industries it regulates. - January 18, 2009

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