Device FDA Inspections: How to Use QSIT to Your Advantage

Date	Feb 26, 2015
Time	11:00 AM EDT
Cost	$287.00
Online

CDRH broke its own device warning letter record in 2013.  And experts predict that trend will continue in 2015.

If you don’t want to be another statistic in the FDA’s warning letter program, read on ...

How did your last FDA inspection go?

If you and your staff need a nuts and bolts explanation of how the FDA is going to inspect you in 2015, FDAnews has partnered with device inspections expert Jodi Scott of the law firm Hogan Lovells to give you the answers.

Please mark your calendar for Thursday, Feb. 26, for a webinar designed exclusively for FDA-regulated device firms.

Ms. Scott is among the regulatory bar’s savviest experts in quality compliance and enforcement, including: QSIT, the FDA’s Quality System Regulation (QSR), adverse event reporting and field action requirements.  And you get to spend 90 minutes with her; asking as many question as you’d like. You’ll gain invaluable insights from a device inspections veteran.

You’ll come away knowing:

•     What does the FDA expect from your firm?
•     What background materials does the FDA research before starting your inspection?
•     How the seven subsystems of the QSIT need to work together within your organization
•     How to advocate for your company in post-inspection environment — without antagonizing the inspector
•     29 tips for what to do once an investigator shows up for an inspection
•     How to respond properly to a Form 483

Book a conference room or an auditorium and invite every team member whose work life is affected by the FDA.  Your entire team can participate at no extra cost. One low registration fee covers every participant at the same location. It’s easy to add additional locations, too, at bargain rates. Simply call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about multisite discounts.

What better time to buttress your compliance efforts in the coming year? Do not hesitate. Sign up TODAY for Device FDA Inspections.

FREE REPORT FOR ALL ATTENDEES
How the FDA Trains and Prepares Investigators
Want to know exactly how that investigator knocking on your door got qualified to be there? How they are trained, promoted, and what experience they have? All the answers are in this complete guide. It covers how the FDA trains its investigators before they are set loose to conduct inspections, and the training investigators receive as they rise through the ranks so you’ll know exactly who you’re dealing with when addressing the next investigator who visits.

Who Should Attend
    Auditors
    QA/QC specialists
    Compliance officers
    Data management and statistics personnel
    R&D staff
    Validation specialists, scientists and engineers
    New employees

Conference Details:
Device FDA Inspections:
How to Use QSIT to Your Advantage
**FDAnews Webinar**
Feb. 26, 2015 — 11:00 a.m. – 12:30 p.m. EST

Easy Ways to Register:
Online:      www.fdanews.com/DeviceFDAInspectionsQSIT
By phone: 888-838-5578 or 703-538-7600