Device FDA Inspections

Device FDA Inspections - Webinar CD/Transcript

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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.

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

Mike Heyl Esq. of Hogan Lovell specializes in post-market compliance and enforcement in the medical device sector, including the FDA’s Quality System Regulation (QSR), adverse event reporting and field action requirements. In addition, he helps conduct internal investigations where companies are accused of alleged regulatory violations; reviews and drafts standard operating procedures; assists with import and export issues; conducts regulatory due diligence; negotiates corporate mergers and acquisitions and initial public offerings; creates and implements corrective action plans; and provides wide-ranging advice on device-related regulatory issues.