Cerulean’s John Avellanet is an internationally renowned speaker, expert and authority on data integrity and lean compliance practices for FDA cGMP, cGCP, QSR, 21 CFR Part 11, Annex 11, ICH and IMDRF. He’s been interviewed and quoted on NPR, CNN, ABC News, Bloomberg News, the Washington Post and other major news organizations.
He has trained FDA investigators and district officers, Health Canada officials, spent over 15 years being directly accountable for data integrity and regulatory compliance, and during his career, passed multiple regulatory inspections. He was personally trained by the authors of 21 CFR 11 to conduct FDA inspections himself. Mr. Avellanet has been called been called “the best in the business” by former FDA and Department of Justice officials.
Trusted by officials at FDA, NIH, DOJ, the HHS OIG, and Health Canada as well as by corporate clients around the world, Mr. Avellanet provides practical, business-savvy solutions to strengthen compliance while lowering costs and reducing risk. He speaks frequently at industry conferences and private organizations around the world.
Recently, Mr. Avellanet co-authored the book, Pharmaceutical Regulatory Inspections (2014), with several current and former regulatory agency officials. Mr. Avellanet’s book, Get to Market Now! Turn FDA Compliance into a Competitive Edge (2010), was featured at BIO 2011 and received numerous five-star reviews from former FDA officials and Amazon.com reviewers. He was also a contributing author to the book Best Practices in Biotechnology Business Development (2008).
Throughout his corporate career, Mr. Avellanet has been personally accountable for regulatory compliance and quality systems (including ICH, ISO, FDA Parts 820 and 11), records management, and IT compliance.
Mr. Avellanet’s regulatory and quality expertise is based on his experiences having to put in place, live under, and be audited upon compliance programs for FDA, DEA, EPA and BIS regulations as well as ISO guidelines. He has since translated his mistakes and successes into client success stories – whether setting up flexible, risk-based GLP/GMP quality systems, putting in defensible document and record retention programs, conducting mock FDA audits, or helping companies recover from FDA inspections and warning letters.
Illustrative of Mr. Avellanet’s advice are:
Mr. Avellanet is a member of the following professional and industry associations:
Mr. Avellanet grew up in the Washington, D.C. area and worked for several local and state government leaders in Alexandria and Richmond, Virginia. He earned his Bachelor’s at the College of William & Mary in Virginia and his Master’s degree at the university of Kansas.
His consulting office is located in Williamsburg, Virginia near the College of William and Mary.
In addition to advising his corporate clients, Mr. Avellanet is a frequent guest lecturer for:
Mr. Avellanet serves on the advisory boards of several industry and professional associations:
Previously, Mr. Avellanet served as a director-at-large board member for the Independent Computer Consultants Association and the IT Compliance Institute.