FDA 483s, Warning Letters & Enforcement Trends – Webinar Recording/Transcript
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FDA 483s, Warning Letters & Enforcement Trends
How should you prepare for your next inspection?
The answer, hiding in plain sight, lies in the analysis of recent FDA enforcement trends. And who better to guide you than top Washington FDA lawyers Chalana Damron Esq. and John Fuson Esq. of Crowell & Moring LLP.
Join them for a 90-minute tour of current FDA enforcement trends. This webinar helps you shape your policies and practices with an eye on keeping the agency at bay.
Presentation Takeaways
- Enforcement trends: 2019 FDA enforcement activity — 483s and warning letters — vs. prior years
- Most prevalent targets of FDA inspections
- GMP violations most often cited in 483s and in warning letters
- Managing inspections to minimize risk of escalation
- How lawsuits are born: The role that FDA enforcement actions play
Strengthen your quality and compliance systems based on proven trends.