FDAnews Announces Device FDA Inspections: Expert Tells All Webinar, Dec. 12

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Device warning letters are on the rise, and experts predict the trend will continue in 2014. Get ready for the next FDA device inspection without antagonizing investigators.

Device FDA Inspections
Expert Tells All
**FDAnews Webinar**
Dec. 12, 2013 — 1:30 p.m. – 3:00 p.m. EST

FDAnews has partnered with device inspections expert Jodi Scott of the Washington law firm Hogan Lovells to give a nuts and bolts explanation of how the FDA is going to inspect devicemakers in 2014

Mark the 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.

Attendees come away knowing:

  •     What does the FDA expect from the firm?
  •     What background materials does the FDA research before starting the inspection?
  •     How the seven subsystems of the QSIT need to work together within the organization
  •     How to advocate 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.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 the 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 devicmakers know exactly who they’re dealing with when addressing the next investigator who visits.

Meet Your Presenter
Jodi Scott, a Partner with Hogan Lovell focuses her practice on assisting the medical device industry in navigating the complex requirements for achieving U.S. marketing authorization and maintaining compliance to the FDA quality system and other postmarket regulatory requirements. Ms. Scott 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. Prior to joining Hogan Lovells, Ms. Scott served for four years as senior FDA legal counsel and, subsequently, four years as principal FDA legal counsel for Medtronic, Inc., where she was instrumental in growing the company's corporate FDA legal practice to meet the needs of their business in an increasingly enforcement-minded environment.

Who Will Benefit
This webinar is a must-attend for every device firm subject to FDA inspection. Must-attend job titles include:

  •         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
Expert Tells All
**FDAnews Webinar**
Dec. 12, 2013 — 1:30 p.m. – 3:00 p.m. EST

$547 per site -- includes webinar registration and audio cds and transcripts

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

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
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since: 12/2011
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