Xavier Health
QA/RA Institute for Medical Device Professionals
 

FDASIA Series


Download Summary of FDASIA Series

Course Format:

  • Webinar

Expert Faculty:

Series Description:

This webinar series will occur semi-annually, allowing you to benchmark where you and your company stand as the provisions of FDASIA go into effect over 2013.  The webinars will 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 the new FDA expectations and requirements.  Our experts will provide company leaders with the tools to stay on course for compliance as the FDA’s expectations evolve over 2013.

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. Or, we have provided a pdf version of the device-relevant actions here:

Download FDASIA Track for Devices pdf

Note: Registrants for this 3-webinar program receive a 10% Discount!

Course Introduction:

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 have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?

Learning Impact:

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

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

0.1 CEU credits available for each hour of coursework.

Receive professional continuing education credits  by attending a course (either live or on-demand) and then completing this evaluation form: FDASIA CEU.  The evaluation form can be submitted to Mason Rick (rickm@xavier.edu).
 

Tuition:

Registrants may register for individual modules separately if desired. Select the module(s) of interest from the list provided above.

Industry: $945.00
†Small Companies: $745.00
†††Startup/Academic: $200.00
Government Official: $0.00

Attendee Types
† A Small Business is one that has less than 100 employees.

††† A Start-up Company is one that manufactures product. A start-up company who provides only services is not included in this category. The start-up company must not have product on the market yet, and therefore no revenue being generated. The start-up company has less than 10 employees.

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.

Logistics:

This webinar is now available for immediate access.