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

• Presenter
• CE Credits
• Certificate of Attendance

Jeremy Allard

Managing Director, GxP Services

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.

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.