Device FDA Inspections - Expert Tells All

A recent study showed 67% more warning letters have been issued to devicemakers in 2012 than in 2008. And experts predict the trend will continue in 2014.

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 2014, FDAnews has partnered with device inspections expert Jodi Scott of the Washington law firm Hogan Lovells to give you the answers.

Please mark your calendar for Thursday, Dec. 12, 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 him; 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 than the year end to buttress your compliance efforts in the coming year? Do not hesitate.