Next Wednesday at the ACI Food Regulatory Summit in Chicago I’ll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here.
Topics that I plan to cover include:
- FDA’s plan to increase frequency of inspections and how it plans to do it
- How to be prepared for FDA’s greatly expanded records access authority
- How to avoid new fees that will be imposed by FDA
- Developing an appropriate strategy to deal with FDA
- Preparing a privileged FDA inspection plan and training
More information about the ACI conference and registration can be found here.