|Don't bury your head in the sand; |
start your response letter ASAP
by Alex Butler
Medical Device Segment Manager, MasterControl
I received a warning letter while working for a leading global manufacturer of dental materials, devices, and instruments. As part of the remediation team assigned to address the citation, which entailed overhauling the company’s entire quality system, I understand that time is of the essence when crafting a response letter and remediation plan. Working many nights and weekends, it took my team eight months to receive our close-out letter, then we spent another year implementing our remediation plan—all while performing our “regular jobs.” It was a grueling process, but I learned a few remediation lifehacks that may save you time and frustration.