Data Integrity: The Key to FDA and GMP Compliance

Speaker

John AvellanetJohn Avellanet

John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.

Mr. Avellanet was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society.

He co-authored the book Pharmaceutical Regulatory Inspections with several current and former regulatory agency officers, and his industry classic, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, was featured highlight of BIO 2011.

In 2011, he was asked by the US Office of Inspector General, Health & Human Services to oversee the multi-million dollar Dr. Comfort Corporate Integrity Agreement (CIA) through 2016.

In 2009 and 2011, Mr. Avellanet won the “Best of Business” award from the US Small Business Commerce Association. His blog, ComplianceZen.com, has been repeatedly named one of the “Top 50 Blogs” worldwide on FDA compliance issues.

Over the past 9 years, he has been interviewed on public radio programs, in numerous industry magazines and multiple news outlets. He speaks frequently for industry conferences and private corporate workshops.

Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance. During his career, he had to defend decisions to investigators, auditors, and litigators alike. He now brings his hard-won, real-world expertise and practical advice to his corporate clients worldwide.

A former FDA and US Department of Justice prosecutor has said of Mr. Avellanet, “He is the best in the business. Period.”

 

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