Secrets of QSIT-Based Medical Device Inspection Preparation
Product Details
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. Each purchase package includes:
- Secrets of QSIT-Based Medical Device Inspections DVD
- The Quality System Inspection Training (QSIT) Manual itself — full text
- FDA’s Compliance Program Guidance Manual — 7382.845: Inspection of Medical Device Manufacturers
- Printable presentation slides in note-taking format
- Troubleshooting Your Quality System: A Guide to Five Devicemaker Quality Compliance Traps Management Report
- Title 21 CFRs - Parts 800-1299 (Medical Devices)
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.
Secrets of QSIT-Based Medical Device Inspection Preparation is available as a training kit including DVD, CD and supplementary training materials.