Food and medical product companies must prepare for and respond to Food and Drug Administration inspections. When the FDA finds violations of the Federal Food, Drug, and Cosmetics Act, the agency often initiates compliance actions, such as issuing warning letters or seeking judicial enforcement action.

Such governmental actions can expose FDA-regulated companies to additional risk in the form of civil litigation by private parties. This webinar addresses these risks and offers strategies to minimize exposure while striking the appropriate balance in responding to both FDA enforcement and civil litigation.

Topics include consumer litigation, such as product liability and consumer fraud, and how issues related to manufacturing, distribution, and labeling may lead to legal action. The session also covers the False Claims Act and its connections to data integrity, good clinical practice, and good manufacturing practice regulation.

Speakers

• Howard Sklamberg | Partner, Washington, D.C.
• Lori Leskin | Partner, New York
• Giselle Joffre | Partner, Boston

Register

• 1-2 p.m. ET
• 10-11 a.m. PT
• 11-12 p.m MT