FDAnews Announces: Device FDA Inspections: How to Use QSIT to Your Advantage Webinar, Feb. 26

Share Article

CDRH broke its own device warning letter record in 2013 and experts predict that trend will continue in 2015. FDAnews has partnered with device inspections expert Jodi Scott of the law firm Hogan Lovells to give device manufacturers a nuts and bolts explanation of how the FDA is going to inspect in 2015 during the Feb. 26 webinar Device FDA Inspections: How to Use QSIT to Your Advantage.

Device FDA Inspections:
How to Use QSIT to Your Advantage
**FDAnews Webinar**
Feb. 26, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/DeviceFDAInspectionsQSIT

CDRH broke its own device warning letter record in 2013. And experts predict that trend will continue in 2015.

How did the last FDA inspection go?

FDAnews has partnered with device inspections expert Jodi Scott of the law firm Hogan Lovells to give device manufacturers a nuts and bolts explanation of how the FDA is going to inspect in 2015.

Please mark the calendar for Thursday, Feb. 26, 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 attendees get to spend 90 minutes with her; asking as many question as they would like. Attendees will gain invaluable insights from a device inspections veteran.

Attendees will come away knowing:

  •     What does the FDA expect from firms?
  •     What background materials does the FDA research before starting an inspection?
  •     How the seven subsystems of the QSIT need to work together within an organization
  •     How to advocate for a company in a 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

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.

Meet the Presenter:
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.

Who Will Benefit:

  •     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:
How to Use QSIT to Your Advantage
**FDAnews Webinar**
Feb. 26, 2015 — 11:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/DeviceFDAInspectionsQSIT

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/DeviceFDAInspectionsQSIT
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.

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Michelle Butler
FDANEWS
+1 (703) 538-7665
Email >
FDAnews
Like >
Visit website