On-Demand Webinar

From Simulation to Success: Stress Testing Your Inspection Readiness

Preparing for FDA inspections can be daunting, but mock inspections offer a powerful tool to ensure compliance and readiness.

By simulating real-world inspection scenarios, organizations can address vulnerabilities proactively, develop robust corrective actions, and foster a culture of continuous improvement. Join Advarra’s GxP compliance expert as he outlines key compliance focus areas and discusses strategies to integrate inspection findings into long-term quality management.

Participants will gain actionable insights into how mock inspections can identify potential gaps in processes, documentation, and adherence to regulatory standards.

Learning Objectives:

  • Understand the elements and expectations of FDA and BIMO inspections
  • Equip attendees with the knowledge to confidently face FDA scrutiny and drive success through preparedness.
  • Identify strategies for improving internal quality structures to better support regulatory inspections
  • Explain why preparation and simulations are critical to a successful BIMO inspection
  • Explore refresher tips for large pharma on executing a successful inspection

Presented By

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Jeremy Allard

Managing Director, GxP Services
Advarra Consulting

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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 representatives from sponsor and site organizations involved in clinical site compliance, quality, vendor management and outsourcing, data management, safety monitoring, drug safety, regulatory affairs, clinical operations, and clinical development.

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