QA

5 Steps to Surviving a Regulatory Inspection

Much of my team’s day-to-day responsibilities come down to planning: planning for good quality assurance practices, planning in case of a regulatory inspection, planning responses to questions during an inspection, and even planning for future inspections in the midst of an ongoing one.

Based on a recent Food and Drug Administration (FDA) inspection at UBC headquarters that returned no observations, this planning has been time well spent. In fact, no findings have been returned in the nearly 40 regulatory authority inspections that the UBC QA team has managed or onsite inspections of manufacturer-sponsored programs that UBC managed. These steps are the backbone of the UBC’s Quality Assurance program and the reason we’ve successfully completed so many inspections.

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