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John Avellanet

Managing Director & Principal

John Avellanet is a former C-level medical device and bio-pharma executive who created, developed and ran a Fortune 50 subsidiary's Records Management and Information Technology departments to meet FDA, ISO, ICH and GHTF compliance requirements.

He co-founded Cerulean in 2006, and today is an internationally acknowledged expert, speaker and syndicated author on lean FDA compliance, records controls, and FDA/ICH Quality by Design.

Mr. Avellanet is the author of the book Get to Market Now! and a contributing author to Best Practices in Biotechnology Business Development.

His work has been syndicated and translated into multiple languages in Europe and Asia.  He is a regular columnist for the quarterly Journal of Commercial Biotechnology where he writes on the practical aspects of FDA compliance and quality systems, and the magazine Pharmaceutical Processing where he writes about IT compliance issues such as Part 11 and Annex 11.

Mr. Avellanet is also the creator of the private FDA advisory program for corporate executives, the SmarterCompliance™ Toolkit, with its monthly SmarterCompliance™ newsletter.

 

Expertise

Throughout his corporate career, Mr. Avellanet has been personally accountable for regulatory compliance (including ICH, GHTF, FDA Parts 820 and 11, and EMEA Annex 11), records management, discovery litigation compliance, and preventing industrial espionage.

Mr. Avellanet's regulatory and quality expertise is based primarily on his experiences having to put in place, live under, and be audited upon various rules and regulations.  He has since translated his mistakes and successes into client success stories - whether setting up flexible, risk-based GLP/GMP quality systems, conducting supplier audits of CROs and CMOs, or helping companies recover from FDA inspection findings and warning letters.

 

Recent Highlights

Illustrative of Mr. Avellanet's advice are:

• The new book, Get to Market Now! (Logos Press)

• Mr. Avellanet co-authored the book, Best Practices in Biotechnology Business Development

• He helps represent industry on the Pharmaceutical Quality by Design advisory panel

• He maintains an FDA compliance and quality systems blog, Compliance Zen

• Mr. Avellanet was awarded lifetime membership in the Who's Who of top executives in the pharmaceutical and life sciences industry

• He was chosen as one of the foremost experts on FDA compliance during new product development by the worldwide 30,000-member Intota organization.

• He has been a frequent guest on radio programs such as Tomorrow's Business and My Technology Lawyer, and has been interviewed in print and on the radio.  Many of Mr. Avellanet's published interviews are available for free download.

 

Professional Activities

In addition to advising his corporate clients, Mr. Avellanet is a frequent guest lecturer for:

• College of William & Mary Mason School of Business

• Virginia Commonwealth University School of Business

• Shenandoah University School of Pharmacy

 

Mr. Avellanet serves on the boards of several industry and professional associations:

• PharmaQbD.com

• BIO IT Coalition

• Global Technology Transfer Organization

•  Inc. magazine's Inner Circle

Last year, Mr. Avellanet served as a director-at-large board member for the Independent Computer Consultants Association and the IT Compliance Institute.

 

Professional Affiliations

Mr. Avellanet is a member of the following professional and industry associations:

• Food and Drug Law Institute

• Regulatory Affairs Professional Society

• Institute of Validation Technology

• Society of Quality Assurance

• Parenteral Drug Association

• Virginia BIO

• Association of Records Managers and Administrators International

 

Related Information

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 & Mary.