RAPS Webcast: Optimizing Standards for Regulatory Use

1.0
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 16 March 2023 (11:00 AM) - Thursday, 16 March 2023 (12:00 PM) Eastern Time (US & Canada)

This webcast will feature an FDA presentation on improving consensus standards to better allow manufacturers to cite them appropriately in device submissions. FDA will also discuss the importance of participating in standards development to optimize standards for regulatory use.


REGISTRATION FEES 

Free


Learning Objectives

Participants will be able to: (1) describe the attributes of a standard that is fit for regulatory use and (2) understand how to contribute to standards development.

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

Regulatory affairs and standards professionals


Instructors:

Scott Colburn

Scott Colburn

Scott A. Colburn is the Director of the Standards and Conformity Assessment Program at the Food and Drug Administration’s Center for Devices and Radiological Health. In this role, Scott is responsible for the Center’s standards recognition and related development activities in 600+ national and international consensus standards committees. In addition, Scott oversees the program’s new Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and the Center’s efforts to optimize standards for regulatory use within the International Medical Device Regulators Forum.

Scott has served in numerous roles in the area of premarket review and voluntary consensus standards development and implementation for medical devices. He is a member of many national and international standards organizations and serves on several policy and leadership committees.


Gail Rodriguez

Gail Rodriguez

Gail Rodriguez is a Senior Advisor to the Standards and Conformity Assessment Program (S-CAP) in FDA’s Center for Devices and Radiological Health. She is responsible for policy development and analysis related to the development and use of standards and leads S-CAP’s strategic planning and communications efforts. Prior to coming to the FDA seven years ago, Dr. Rodriguez served in various policy, sales, marketing and training roles in the radiopharmaceuticals industry, and in leadership positions for several diagnostic imaging associations. She earned her Ph.D. in Political Science, with an emphasis on health policy, from the University of Kansas.


Cancellations

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.

 

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event. 

Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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