Back by Popular Demand, Cerulean’s John Avellanet will speak at 8th Annual Contract & Supplier Conference on how to prove to FDA and Big Pharma's auditors that your supplier management works and is reliable.
For its September 24-25th Eighth Annual Contracting and Outsourcing Conference in New Brunswick, New Jersey, Contract Pharma and Rodman Publishing will host Cerulean’s Managing Director, John Avellanet, providing more entertaining stories, real-world experiences, and practical advice.
Mr. Avellanet will speak to pharmaceutical executives on how to prove to the US Food and Drug Administration and its inspectors that your supplier qualification and outsourced services oversight program is effective and meets all the regulations.
Based on his own personal career experiences as a C-level executive accountable for regulatory compliance to the FDA, plus his conversations with FDA officials, Mr. Avellanet will discuss:
• Red flags to keep an eye out for during due diligence and on-going supplier reviews
• Key quality agreement components for outsourced service provider contracts
• What to look for when auditing supplier records
• Example metrics to collect and review to prove proactive supplier management
Mr. Avellanet has gained tremendous acclaim on his speeches, workshops and teleconferences for various companies and venues around the country. Testimonials cover his speaking page on his website (http://www.ceruleanllc.com/Speaking.htm) and conference organizers repeatedly note that he gets the highest evaluations of any of their speakers. In addition to the 8th Annual Contracting and Outsourcing Conference, you can see Mr. Avellanet as he chairs the FDA Supplier Management Congress in August 19-21, or as he runs a workshop on defensible documents at the AdvaMed MedTech Conference on October 12th.
If you’d like to attend Contract Pharma’s Eighth Annual Contracting and Outsourcing Conference, visit http://www.contractpharma.com/2009conference
John Avellanet is the author of more than 100 articles, is the FDA compliance columnist for several international industry journals, and is the co-founder of the private compliance advisory firm, Cerulean Associates LLC. Every month, he publishes the regulatory intelligence and quality systems advice 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 blog, http://www.ComplianceZen.com, or through his company’s website: http://www.ceruleanllc.com
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