Device FDA Inspections - Webinar CD/Transcript
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 Mike Heyl of the Washington law firm Hogan Lovells to give you the answers.
Mr. Heyl 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. 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
What better time than the year end to buttress your compliance efforts in the coming year? Do not hesitate. Order the Device FDA Inspections webinar and transcript set today.