Always Inspection-Ready: Mastering FDA Inspection Preparation and Response
Автор: Nelson Labs
Загружено: 2025-08-19
Просмотров: 206
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This webinar offers a focused look at preparing your facility, emphasizing internal audits and structured readiness strategies to support sustained compliance. We’ll explore best practices for front-room and back-room coordination, team roles, and engaging with FDA investigators.
Learn how to ensure your quality system records—including investigations, CAPAs, and contamination controls—can withstand regulatory scrutiny. Attendees will also gain insights into data integrity and alignment with current FDA guidance, such as policies on delaying or limiting inspections. We’ll outline how to effectively manage and respond to Form 483s and warning letters, with emphasis on strong corrective action planning and communication.
Whether preparing for a pre-approval, pre-license, or routine GMP inspection, this session provides practical tools to help regulatory and quality teams maintain a state of readiness and reduce inspection-related risk.
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