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14th Annual FDA Inspections Summit

Event | 10.25.19, 5:10 AM EDT - 6:00 AM EDT

Address

Bethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd, Rockville, MD 20852

Doing an annual lookback at the 483s and warning letters the FDA has issued can provide great insights to prepare you for your next inspection and will give you a glimpse of some of the areas the FDA is focusing on. There are top citations that come up year after year, such as insufficient CAPA investigations and not following your SOPs, but new patterns crop up all the time. Come hear a new analysis of the trends and what you can do to pass your next inspection with flying colors.


Counsel Chalana Damron will be presenting this session titled "FDA 483 and Warning Letter Trends" on Friday, October 25th at 9:10 am.

For more information, please visit these areas: Mass Tort, Product, and Consumer Litigation

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.