Titan Pharmaceutical thinks it's got it's act together... until the FDA Investigator arrives!  "No Problem" The Pre and Post Approval Inspections

"No Problem" is the second set in our training series. It is also partnered project, which was developed with senior trainers from Roche, Schering Plough, Merck, and Bayer Corporation for use in their own training programs. This program was developed in 1997 but is still totally relevant and the information current. 

This is a highly entertaining two video set with a wry sense of humor that 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, mistake and cover-up to another attempting to put forward it's best face to the investigator and get it's drug approved. Their efforts are to no avail and the video culminates in the receipt of a "Form 483" from the FDA Investigator to the company.

In Part 2 corrections are made and the investigator returns for a "Post Approval Inspection"  Unfortunately, the company fares no better.  More infractions and errors are found and the company's approval is ultimately delayed. Even though presented with a sense of humor, 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.

These videos are very valuable for preparing your employees on what to expect from the Pre and Post Approval Inspections.

This is a step-by-step series designed to make it easier for trainer's of every skill level. It includes a two video set with an 80 page trainer's guide.

Topics 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

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