Dealing with FDA and Their Inspection Enforcement Tools - Webinar Recording/ Transcript
Dealing with FDA and Their Inspection Enforcement Tools
Successfully navigating inspections is essential to your relationship and reputation with the FDA. And, of course, it’s key to securing approval for your product and getting it to market.
Make the most of your next inspection with insights from a former Associate Chief Counsel for Enforcement at the FDA.
- Best practices for answering FDA Form 483 observations
- Strategies for avoiding warning letters and serious enforcement actions
- Tips for building agency confidence in site operations
- Tools for assessing company exposure to regulatory risk — including identifying hot-button issues for inspections
- Knowledge of FDA factors that renders enforcement or escalations
Avoid escalation to injunctions by knowing how to respond to FDA enforcement actions.