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RAPS Chapters Webcast: Voluntary Consensus Standards: A Key to Efficient Medical Device Submissions

1.5
RAC Credits
Monday, 19 October 2020 (12:00 PM) - Monday, 19 October 2020 (1:30 PM) Eastern Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.

Description

Gain in-depth understanding of the value that voluntary consensus standards bring to regulatory science. During this presentation, Dr. Rui Peng will introduce attendees to the benefits associated with the use of FDA-recognized consensus standards, for manufacturers, patients, and public health. He will explain how the Center for Devices and Radiological Health’s (CDRH) standards program works and conclude with best practices on how to effectively cite standards in submissions, including the use of declarations of conformity.

We encourage regulatory affairs attendees to bring their standards counterparts and vice versa (if they have them) and to become familiar with the Appropriate Use of Voluntary Consensus Standards guidance. 

A Q&A session will be at the end. 

This event is brought to you by RAPS Chapters to encourage knowledge sharing and community development. RAC holders may claim 1.5 RAC recertification credits.

Learning Level: Intermediate

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. 

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured FDA Speaker:
Rui Peng, Ph.D., senior standards advisor, Standards and Conformity Assessment Program, Center for Devices and Radiological Health, US Food and Drug Administration

Register