DVD – multi-user single site: Secrets of QSIT-Based Medical Device Inspection Preparation

August 2014
Also Available:

Now, the man who literally wrote the book on QSIT inspections can teach your staff in a cost-effective, interactive way. Bring the same training used by FDA inspectors right to your conference room.

Tim Wells— former Team Leader for the FDA’s Quality System Inspection Reengineering Project — coaches devicemakers at all levels on how to understand QSIT and use its ever-changing nuances to pass their next inspection.

This one-of-a-kind DVD training tool features a unique insider perspective as Mr. Wells — a 24-year FDA veteran — shows how the FDA determines your risk profile. And points out red flags that alert you when an inspector is sniffing for a specific problem.

Viewers can clearly identify the key learning points as they are highlighted on screen and elaborated by Tim through his fine-tuned examples, interactive exercises, group discussion and a final exam.

In just 180 tightly focused minutes, you and your staff will discover best practices for passing FDA device inspections

This DVD and related training aids include valuable take-away points and best practices, such as:

·   Understanding the differences between “top-down” inspections as prescribed in the QSIT, and the “bottom-up” approach FDA inspectors are using more and more

·   When devicemakers can rely on QSIT principles, and when inspectors may go “off book”

·   Getting top management involved with internal audits and compliance master plans

·   The specific red flags the FDA looks for (did you know an inspector’s request for shipping records is a red flag?)

·   The five types of QSIT inspections

·   Non-QSIT areas FDA also inspects

·   And much more…

Will you pass your next FDA inspection? You will – if you get prepared today. Make the commitment! Order your DVD kit today.