On-Demand Webinar

Is Your Site Ready for an FDA Inspection?

For sites, understanding the FDA’s expectations during an inspection can help resolve staff apprehensions and 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 site for an FDA inspection, and gain insight into a site’s responsibility for assuring GCP compliance as well as the protection of subjects’ rights and safety.

Learning Objectives:

  • 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
  • Identify site responsibilities to assure the protection of subject rights, safety, and well-being
  • Best practices to assure study integrity and GCP compliance

Presented By

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Leslie Paul

Director, Quality Center of Excellence
Advarra Consulting

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Anthea Dransfield

Managing Director, Quality Center of Excellence
Advarra Consulting

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Who should watch?

This content applies to sites, growing biopharma, and pharma companies - anyone involved in handling clinical site compliance, Quality, Procurement Director, Vendor Management, Outsourcing Manager, Strategic Sourcing, Proposal Manager, VP/Director of Quality, Manager of Quality Data Manager, IT Manager Research, Pharmacovigilance, Safety monitoring, drug safety, Environmental Health and Safety Officer, Biosafety Officer, Laboratory Safety Officer Clinical Development Manager, Clinical Development Lead, Director of Regulatory Affairs, Clinical Trials Regulatory, Clinical Research, Regulatory Program Supervisor, VP Regulatory Affairs, and Regulatory Scientists.

CE Credits

This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

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.

If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education 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