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Thompson Interactive - FDA Inspections: Be Ready

Event | 01.07.09, 12:00 AM UTC - 12:00 AM UTC

With a new Administration, and a new FDA Commissioner, inspections are almost certain to increase. And with the enforcement powers granted under FDAAA, being prepared for an inspection is now more important than ever.

Those firms that have a good understanding of its compliance profile, with staff properly trained, is more likely to have a successful inspection than a firm that is unprepared.

In this 90 minute audio conference CD recording, compliance attorney and expert Cathy Burgess will educate you and your staff on what it takes to pass an FDA inspection, both in terms of meeting FDA regulations, and in management of the inspection process itself.

Insights

Event | 12.04.25

ACI 30th Annual Conference on Drug & Medical Device Litigation

Dan Campbell with Speak on the panel "Mastering MDL Case Management: What Proposed Rule 16.1 Really Means for Consolidated Litigation."
Rule 16.1 attempts to guide early case management in MDLs, impacting litigation pace and costs. Permissive language like “should” instead of “must”, could lead to inconsistent applications. This panel will explore the rule’s anticipated impact and implications for procedures.