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2009 News Center

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December 17:  Cerulean receives 2009 Best of Business award in the small business category by the Small Business Commerce Association.

November 3:  Back by popular demand, Cerulean will hold an encore live Bulletproof Yourself against FDA Enforcement in 2010 webinar and teleconference on January 11th.  Register today.  Read the press release for more.

September 18:  AdvaMed hosts John Avellanet speaking on putting in place a records management program that meets FDA requirements and minimizes legal liability.

August 27:  In response to FDA Commissioner Hamburg's new "get tough" approach to regulatory enforcement, Cerulean's John Avellanet has revised his popular Bulletproof Yourself against FDA Enforcement webinar with additional information, more hot topics for the FDA, and dozens more specific recommendations.  Read the press release and register.

July 27:  Back by popular demand, Cerulean's John Avellanet will speak at the 8th Annual Contract Pharma Contracting and Outsourcing Conference in New Brunswick, New Jersey.  An advanced copy of the slides is also available to SmarterCompliance newsletter subscribers.

July 14:  This August, the 3-day FDA Supplier Quality Management Congress will be chaired by John Avellanet.

June 9:  Virginia Commonwealth University hosts Cerulean's John Avellanet on the role of IT in regulatory compliance, from Sarbanes-Oxley to HIPPA.

June 5:  John Avellanet signs book contract with Logos Press to craft book on the regulatory and quality systems landscape in the era of personalized medicines, based in part upon his series on personalized medicine and compliance in the SmarterCompliance newsletter.

May 21:  Cerulean releases its new recorded seminar and toolkit, How to Improve Data Integrity in Your Regulatory Submission, and publishes a new blog, Compliance Zen.  Read the press release.

April 15:  The National Institutes of Health will host Cerulean's managing director on April 21st to speak about the challenges facing biotechnology executives and companies in the decade ahead.

April 2:  Cerulean's John Avellanet spoke to more than 400 top executives from five different countries on the regulatory requirements for records and document retention under the FDA GLPs, GCPs, and GMPs.

March 18:  MasterControl's GxP Lifeline interviews Cerulean's Managing Director on Part 11, computer virtualization, and his SmarterCompliance™ FDA advisory program.

March 2:  FDA agenda for 2009 matches Cerulean's December 2008 forecast.

February 20:  Two new FDA quality systems compliance resources are published by the SmarterCompliance™ newsletter and Cerulean Associates LLC.

February 5:  Biotech Blog publishes Cerulean's new article, Solving the FDA Crisis, on steps Congress can take to strengthen the FDA and improve the safety of food and medicinal products.

January 30:  The Association of Medical Diagnostic Manufacturers (AMDM) welcomes Cerulean as new member providing "valuable FDA advice and compliance intelligence."

January 28:  Pharmaceutical Processing magazine features Cerulean's 2009 forecast as its cover (plus an excerpt for its lead article) for its January issue.  Read the press release.

January 9:  Cerulean publishes its annual FDA forecast and planning analysis and report.  2009 will be a year of transition for the FDA, resulting in an agency eager to prove its mettle and toughness on the pharmaceutical, biotech and medical device industries it regulates. The report summarizes more than 40 expected FDA initiatives for the new year, including increased executive scrutiny, regulatory changes, and guidance issuances expected over the next twelve months.

 

 

 

Click here for Cerulean's 2008 press releases.

For news releases from 2007 or earlier, or to get an electronic press kit, please contact us.