Sarah Brew of Faegre Baker Daniels will speak on "FDA Targeted Inspections – Determining If Your Facility Is High Risk" during a 60-minute audio conference on Wednesday, August 15, 2012.
With the Food Safety Modernization Act (FSMA) providing FDA with broad new inspection authority, targeted inspections will focus on high-risk facilities. FDA recently disclosed the criteria it will use to determine which facilities are high risk, and inspectors are also armed with enhanced records access authority, which will increase significantly in scope once preventive controls regulations are issued and effective. But even now, food and beverage companies are experiencing more robust inspections, longer in duration, with more environmental testing and with requests for records and photographs.
In this audio conference presentation, Sarah will discuss the latest hot-button issues related to FDA inspections, as well as how to prepare for FDA's enhanced inspection authority and actions to take both before and during an inspection. The audio conference will cover:
- How FDA will determine if a facility is high risk
- What to expect when the inspector arrives
- How to handle requests for documents or photographs
- When FDA can recover inspection fees
- How FDA's inspection and records access authority will expand with the implementation of preventive controls regulations
- What you can do now to prepare for your next inspection
Sponsored by FX Conferences, registration fee is $199.