On-Demand Webinar

Inspection Readiness: Before. During. After

Your organization has received a Form 482 Notice of Inspection. What now?

While they are often stressful and sometimes unforeseen, FDA inspections are intended to ensure the protection of human research subject rights, safety, and welfare as they are involved in FDA-regulated clinical studies. Understanding the expectations of the FDA during inspections can help to resolve the apprehension of an inspection and provide the landscape for a successful inspection as well as ensure effective post-inspection activities.

Leslie Paul, Director, and Anthea Dransfield, Managing Director at Advarra Quality Center of Excellence will explore strategies for preparing for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.

Learning Objectives:

  • Learn successful strategies for a proactive approach to FDA Inspections
  • Gain an in-depth understanding of regulation non-compliance and post-inspection activities
  • Identify critical issues regarding subject rights, safety, and/or welfare

Presented By

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Anthea Dransfield

Managing Director
Advarra Consulting – Quality Center of Excellence

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Leslie Paul

Director
Advarra Consulting – Quality Center of Excellence

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Who should watch?

This content applies to sponsors and CROs, growing biopharma and pharma companies - anyone involved in 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

Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations. 

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

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