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  5. CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct - October 5, 2017
  1. CDER Small Business & Industry Assistance (SBIA)

CDER SBIA extended webinar: Electronic Drug Registration & Listing Using CDER Direct - October 5, 2017

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Presentation Slides and Recordingsdisclaimer icon       This event is FREE            AGENDAdisclaimer icon

  

Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA)

Regulatory Education for Industry (REdI)

Invites you to join us for our extended webinar

Electronic Drug Registration & Listing Using CDER Direct

Thursday, October 5, 2017

Attend In-Person or Virtually

 

 

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Just in time for the registration renewal and the first required drug listing recertification period, this in-person and on-line event is intended to educate and assist all drug firms with the registration and listing process. Each session will focus on a specific submission (Establishment Registration, Product Listing, Listing Recertification, Labeler Code Requests, 503B Product Reporting) and walk through the creation and submission of each using FDA’s free authoring tool: CDER Direct.

Additionally, for those who attend in person, experts and helpdesk technicians will be on hand to answer regulatory and technical questions, and assist with submissions.

KEYNOTE: The New 207 and What You Need to Know.
Speaker:
Leyla Rahjou-Esfandiary, PharmD
Team Lead
Data Quality and Compliance Team
Drug Registration and Listing Staff (DRLS)
Office of Program and Regulatory Operations (OPRO)
Office of Compliance (OC) | CDER | FDA

Advance registration is required.
When you register, you may choose to attend either on-site at the Tommy Douglas Conference Center (TDCC) or virtually online via Adobe Connect. We ask that you please honor your registration commitment. If you need to change your registration status, please email us at cancelation@SBIAevents.com.

 

This 1 day webinar has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.

For more information on
CDER SBIA
(866) 405-5367 | (301) 796-6707 | CDER Small Business and Industry Assistance (CDERSBIA@fda.hhs.gov)
 CDER SBIA Learn

If you've never used Connect Pro, get a quick overview: http://www.adobe.com/go/connectpro_overview

Test your connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm

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