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New FDA Compliance Blog Started
Williamsburg, VA
Thursday, May 21, 2009
Cerulean's managing director, John Avellanet, has finally given in and started a blog of basic FDA advice on quality systems and regulatory compliance: Compliance Zen.
Compliance Zen offers practical tips and short "how-to" articles on FDA-related topics such as Quality by Design, lean FDA compliance, records management, and Part 11 compliance. The blog also provides quick management and leadership tips gleaned from a mix of Mr. Avellanet's personal experiences plus independent business management research. Included in the blog are reviews of leadership books with relevance to compliance, quality systems, and regulatory affairs executives (excerpted from his SmarterCompliance newsletter's Featured Reading section).
Compliance Zen is hosted on TypePad and can be visited at: http://www.ComplianceZen.com
Concurrent with the blog publication, Cerulean has released Mr. Avellanet's recorded seminar, How to Improve Data Quality and Record Integrity in Your NDA, 510(k), or BLA that includes all the individual slides, a pre-submission data checklist, a 3-page regulatory submission data integrity-controls matrix, a pre-study data checklist, a post-study data checklist, and multiple article reprints, FDA guidance documents and presentations. The recording and resource kit may be either downloaded or obtained on a CD through the Cerulean website at http://www.ceruleanllc.com
Mr. Avellanet's next public speech with be at Virginia Commonwealth University's school of business on Friday, June 19th in Richmond, Virginia.
John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of a private compliance advisory firm, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his website: http://www.ceruleanllc.com
Compliance Zen offers practical tips and short "how-to" articles on FDA-related topics such as Quality by Design, lean FDA compliance, records management, and Part 11 compliance. The blog also provides quick management and leadership tips gleaned from a mix of Mr. Avellanet's personal experiences plus independent business management research. Included in the blog are reviews of leadership books with relevance to compliance, quality systems, and regulatory affairs executives (excerpted from his SmarterCompliance newsletter's Featured Reading section).
Compliance Zen is hosted on TypePad and can be visited at: http://www.ComplianceZen.com
Concurrent with the blog publication, Cerulean has released Mr. Avellanet's recorded seminar, How to Improve Data Quality and Record Integrity in Your NDA, 510(k), or BLA that includes all the individual slides, a pre-submission data checklist, a 3-page regulatory submission data integrity-controls matrix, a pre-study data checklist, a post-study data checklist, and multiple article reprints, FDA guidance documents and presentations. The recording and resource kit may be either downloaded or obtained on a CD through the Cerulean website at http://www.ceruleanllc.com
Mr. Avellanet's next public speech with be at Virginia Commonwealth University's school of business on Friday, June 19th in Richmond, Virginia.
John Avellanet is the author of more than 100 articles, is the compliance columnist for several international industry journals, and is a former C-level biotech and medical device executive for a Fortune 50 subsidiary. As the co-founder of a private compliance advisory firm, he publishes the monthly executive newsletter, SmarterCompliance™. He is a frequent speaker at corporate workshops, industry conferences, and meets regularly with regulatory officials. Learn more about Mr. Avellanet on his website: http://www.ceruleanllc.com
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John Avellanet
Managing Director
Cerulean Associates LLC
Williamsburg, VA
757-645-2864
First Url: ComplianceZen
Second Url: Data Integrity in FDA Submissions
