RAPS Chapters Webcast: Putting Consensus Standards to Work: the FDA’s Accreditation Scheme for Conformity Assessment (ASCA)

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Tuesday, 17 November 2020 (12:00 PM) - Tuesday, 17 November 2020 (1:00 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

Learn about the newest initiative in FDA’s Standards and Conformity Assessment Program: the Accreditation Scheme for Conformity Assessment (ASCA). Under the ASCA Pilot, FDA will accredit qualified testing laboratories to certain FDA-recognized consensus standards, with the expectation that less information and supporting documentation will be needed in medical device submissions, thereby streamlining the review process. 

During this session, the FDA will introduce the ASCA Pilot expectations and describe how the Pilot will work to improve the device approval and clearance processes. It will close with practical advice on how to effectively participate in the ASCA Pilot and a Q&A session.

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 event is brought to you by RAPS Chapters to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.

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:
Scott A. Colburn, CAPT, USPHS, director, Standards and Conformity Assessment Program, Center for Devices and Radiological Health, US Food and Drug Administration

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