12:00 PM - 02:00 PM
FDA Inspections 101

- Unannounced FDA visits – how to prepare and react
- Preparing for FDA audits / PAI preparation – what training should look like for key players
- Basic concepts that should be employed by everyone regulated by the FDA – review of quarterly quality topics to keep current

02:00 PM - 04:00 PM
Company Preparedness

- How a company can prepare for situations like this – training of SMEs and beyond
- How a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business

* Includes break

12:00 PM - 03:00 PM
Observations and Lessons Learned

- How should a company respond to 483 observations or a warning letter – deadlines, tracking, and closures
- Lesson learned – reviews of the observations and overall inspection experience

* Includes break

03:00 PM - 04:00 PM
Real Life Situations

- Case Scenarios – review of real-life scenarios that you could encounter during inspections