John Avellanet
Managing Director & Principal Consultant at Cerulean Associates Llc
Based in Williamsburg, United States
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Seniority
Director
Department
General Business & Management
Location
Williamsburg
Industry
Medical Equipment Manufacturing
Company size
1 to 10
Contact information
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j•••••••@ceruleanllc.com
Phone
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Background
About John Avellanet
Award winning FDA compliance expert and speaker. Co-author of the book Pharmaceutical Inspections (2014), author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010), co-author of the book Best Practices in Biotechnology Business Development (2008). Author of the ComplianceZen.com blog. Frequent speaker at industry events, business schools and with FDA officials. In 2006, founded the lean compliance FDA consulting firm, Cerulean Associates LLC Trained as an FDA Part 11 inspector. Provides multiple, cost-effective and FDA inspection-passed quality management and data integrity consulting services to clients. See for more. Specialties: simplifying and streamlining FDA quality systems and regulatory compliance for QSR, cGMP, cGCP and cGLP, mock FDA audits and compliance gap assessments, data integrity auditing and compliance consulting (including Part 11 and Annex 11 compliance), and FDA recordkeeping and archival integrity consulting.
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