Series Description

The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule; there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation had not occurred in over a decade and have had an impact on the Medical Device Industry. These new requirements went into effect in 2013; were you prepared?

Register for both webinars and receive a 10% discount!

 

Expert Faculty

Steve Niedelman
Lead Quality System & Compliance Consultant
King & Spalding

Jim O'Reilly, JD
Professor
University of Cincinnati

 

Course Introduction

This webinar series allows you to benchmark where you and your company stand as the provisions of FDASIA went into effect over 2013. The webinars provide details of the new law that directly impact the Medical Device Industry from experts and the FDA. Use the FDASIA benchmarking webinar series to evaluate your company’s compliance to these FDA expectations and requirements. Our experts provide company leaders with the tools to stay on course for compliance as the FDA’s expectations evolve.

The module introduces the FDA provisions/requirements and launches the discussion on the impact of FDASIA.

NOTE: The FDA has created "FDASIA Track" on their website in order to track progress on guidances and reports required by FDASIA over the next four years.


Learning Impact

During the course of this webinar series, some of the provisions that are discussed include:

  • New 510(k) requirements
  • The Unique Device Identifier system
  • Changes to FDA letter practices to the Industry
  • User Fees
     

Who Should Attend

All functions involved in Product Life Cycle activities including professionals in the areas of QA, RA, Engineering, Manufacturing, Marketing, Service, and Clinical Affairs.


Certification

0.1 CEU credits available for each hour of coursework. Receive professional continuing education creditsby attending a course (either live or on-demand) and then completing this evaluation form: FDASIA CEU.  The evaluation form can be submitted to Marla Phillips (phillipsm4@xavier.edu). To receive full credit, users must be individual, paying members with a registered QARA Institute account.


Tuition

INDUSTRY: $350.00

ENROLL NOW (INDUSTRY)

SMALL BUSINESS: $275.00

A small business has fewer than 100 employees.

ENROLL NOW (SMALL BUSINESS)

STARTUP/ACADEMIC: $75.00

A startup company manufactures products. A startup company which only provides services is not included in this category. The startup company must not have product on the market yet, and therefore does not generate any revenue. The startup company has fewer than 10 employees.

ENROLL NOW (STARTUP/ACADEMIC)

GOVERNMENT OFFICIAL: $0.00

ENROLL NOW (GOVERNMENT)