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.

Order Your Copy Today!

DVD

Available Format

DVD — $397

(Add $10 shipping and handling per DVD for DVDs shipped to the US, or $35 per DVD for DVDs shipped elsewhere. VA residents, please add 6 percent sales tax.)

Meet the Instructor

Tim Wells has more than 36 years of experience in the field of FDA-regulated healthcare products. He is president of the worldwide consultancy QualityHub Inc., which he started in 2000 after a 24-year FDA career that included stints as a field investigator plus 10 years at CDRH as a branch chief in the Office of Compliance. He is best known for his role as the Team Leader for the Quality System Inspection Reengineering Project, where he co-authored the QSIT guide and other key medical device regulatory documents. Mr. Wells has published numerous articles and given dozens of presentations worldwide, and is the recipient of numerous awards including MDDI’s 100 Notable People in the Medical Device Industry.

Our Guarantee

Your risk is zero when you purchase under our money-back guarantee. Not satisfied with the Secrets of QSIT-Based Medical Device Inspection Preparation DVD? return it within 30 days (in reasonable condition) for a 100 percent refund of your purchase price (less shipping/handling).