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Upcoming Events

Join Cerulean's John Avellanet at these upcoming cGXP training workshops, webinars, and conferences. Sessions include data integrity, supplier quality oversight, FDA recordkeeping, quality system best practices, and preparing for inspections from FDA, EMA and ISO.

"Simply put, John Avellanet is the best in the business. Period."
- N. Singer, former US DOJ and FDA prosecutor

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Latest Article

8 Common FDA Supplier Quality Mistakes

February 4, 2015

Drawing on FDA Turbo 483 database analyses, warning letter reviews since 2010, and the statements of FDA officials over the past four years, there are eight ways in which companies typically fall short in their supplier oversight and qualification activities:  Internal v. external supplier confusion  Inadequate supplier criteria  No ongoing monitoring  Poor supplier control records […]

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Client Success Stories

Cerulean's John Avellanet has the expert knowledge and the real life experience to get quality systems up & running fast. For our QA system, he quickly showed us: (1) how to prioritize quality and regulatory compliance solutions by risk to patient and risk to the business; and (2) how to take a typical SOP and turn it into a streamlined, flexible process. Cerulean's practical approaches are wonderful.

- Allan Staley, President, Hampton, Virginia

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