John Avellanet is a former Fortune 50 combination device C-level executive who created, developed and ran his company’s Records Management and Information Technology departments to achieve ISO, FDA, DEA and HIPAA compliance. During this time he served as an internal consultant to regulatory affairs and quality assurance, and helped spearhead the revision of FDA compliance at the biotech and device firm to meet the new 21st century expectations of the FDA.
For more than 16 years, he has been personally accountable for regulatory compliance and preventing records loss in new product development environments.
He has a breadth of experience designing, implementing, and maintaining quality systems and regulatory compliance programs to meet FDA 21 CFR 58, 210/211, 820/822, and Part 11 compliance, EU Annex 11, the ICH and GHTF guidelines, plus ISO 13485, 17799, 17025, and 15489.
In 2006, Mr. Avellanet founded Cerulean Associates LLC to bring all of his real-world experiences and insights to others, and has since become a leading expert on lean FDA compliance, regulatory affairs, quality systems and records management, especially in the arenas of new product development and commercialization.
He’s published over a hundred articles, many of which have been syndicated internationally and translated into multiple languages throughout Europe and Asia, and prior to writing Get to Market Now!, was a contributing author to Best Practices in Biotechnology Business Development. He is the regular compliance columnist for the international Journal of Commercial Biotechnology and publishes a monthly FDA, ICH and GHTF compliance intelligence newsletter, SmarterCompliance™, read by executives around the world as a way to keep up to date on regulatory trends and cost-effective quality and compliance tactics.
He is a frequent speaker at FDA industry events, online compliance seminars, and local business schools, and talks often with regulatory officials.
Mr. Avellanet holds corporate workshops for compliance departments and business management teams to help them understand how to balance regulatory compliance expectations with bottom line realities. Both his clients and several government agency officials recommend him as an independent subject matter expert to help companies cut through consultant clutter and avoid costly mistakes.
Today he serves on the board of several industry organizations including the PharmaQbD advisory panel and the editorial boards of the Institute of Validation Technology and the Journal of Commercial Biotechnology. He serves as an independent compliance consultant through his Cerulean consultancy firm.
Mr. Avellanet grew up in the Washington, D.C. area. He earned his Bachelor’s degree at the College of William & Mary in Virginia and his Master’s degree at the University of Kansas. His office is located in Williamsburg, Virginia.