Senior Director, Life Sciences - Regulatory & Quality
FTI Consulting
Poor quality always carries a cost. Catch quality issues early, and costs are reduced. But once quality issues leave the loading dock, costs can escalate. Few remediation efforts do more damage, both financial and reputational, than a field action. Field actions invite increased scrutiny, trigger expensive investigations. and in some cases require the manufacturer to recall product from the field. This session focuses on the required activities and typical challenges associated with a product recall, suggests best practices and provides participants with an understanding of what the FDA calls “Recall Readiness.”