Device FDA Inspections - Webinar CD/Transcript

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Device FDA Inspections: How to Use QSIT to Your Advantage

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.

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

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

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.

This is a must for every device firm subject to FDA inspection including:

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

Jodi Scott Esq. of Hogan Lovell focuses on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to FDA’s quality system and other postmarket regulatory requirements. She has also spent considerable time developing and implementing strategies to manage FDA-initiated enforcement actions, such as the issuance of FDA Form 483s, untitled letters, Warning Letters, and consent degrees of permanent injunction. Additionally, she assists companies in developing regulatory strategies and preparing product applications, including IDEs, 510(k)s, and PMAs; with compliance matters, including MDRs, recalls, and GMPs; in addressing regulatory due diligence issues; and with FDA training programs.