On-Demand Webinar

Sponsors: Are Your Sites Ready for an FDA Inspection?

For sponsors and sites, developing a clear understanding of the expectations in planning and hosting an inspection can provide the landscape for a successful inspection, all while ensuring successful critical post-inspection activities.

Join us to explore the latest strategies for preparing your sites for a health authority inspection. How do sites integrate sponsor-provided technology and current data management best practices to avoid costly study delays? Register now to gain insight into a site’s responsibility for assuring both good clinical practice (GCP) compliance and the protection of subjects’ rights and safety.

Learning objectives:

  • Gain valuable insights for integrating sponsor-provided technology to become inspection ready
  • Learn successful site-specific strategies for a proactive approach to FDA inspections
  • Gain an in-depth understanding of an FDA inspection and post-inspection activities for sites and sponsors
  • Understand best practices to assure study integrity and GCP compliance

Presented By

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Leslie Paul

Managing Expert, GxP Services
Advarra

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Stuart Cotter

Vice President, Product Management
Advarra

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Assistant Clinical Professor, Internal Medicine and Pediatrics
Conventus Site Medical Director for UBMD

Adult Transitional Sickle Cell Program Director Department of Medicine
Jacobs School of Medicine and Biomedical Sciences University of Buffalo

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Who should watch?

This content applies to sites, growing biopharma, and pharma companies.

CE Credits

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

This event may qualify for continuing education (CE) credits. Please check with your professional organization(s) to determine whether the event meets their CE eligibility requirements.

Certificate of Attendance

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.

DATE: June 17, 2021
Time: 1 pm ET | 10 am PT
Duration: 1 hour

Register Now