No Problem
This two video series delves into the misdeeds of a fictitious pharmaceutical company as they prepare for the release of a new drug and the required FDA Pre and Post Approval inspections.
In Part 1 the hapless company ambles from one blunder and cover-up to another attempting to put its best face to the investigator and get its drug approved. Their efforts are to no avail and they receive a “483".
In Part 2 corrections are made and the investigator returns for a "Post Approval Inspection" The company fares no better. More errors are found and the company's approval is ultimately delayed. This series strongly emphasizes the need for everyone's cooperation and attention to detail when preparing for either inspection and the negative consequences that can occur when an individual doesn't follow Current Good Manufacturing Practices.
Topics covered include:
- A History of the GMPs
- Etiquette of Greeting an FDA Investigator
- Handling an FDA Inspection
- The Pre and Post Approval Processes
- Ethics and Criminal Liability
- The Exit Interview
- Validation Definitions
- Process Validation
- Change Control
- The Importance of cGMP training
Running time: 30 minutes
