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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

FDA’s New Inspection Protocol Begins to Have Impact

December 20, 2016

The FDA’s New Inspection Protocol Project (NIPP) is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current average of 30 percent to a target of 50 percent. “As a pharma company if you’re going to submit a new drug, instead of a 30 percent chance of getting […]

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Client Success Stories

John's approach to Part 11 compliance was skillful in emphasizing how pharma and biotech companies can balance bottom lines to align with FDA expectations. He demystified the technical concepts of Part 11 and translated them into real-world best practices to help us manage patients' safety, rights, and data integrity.

- - Mai Nguyen, Senior Manager, R&D Quality and Compliance, Boston, Massachusetts

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