Solve compliance problems, lower costs & reduce risk with trusted consulting and training to streamline
FDA compliance & strengthen your data integrity.
Find out how →
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
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 […]Read the article