FDA Pre-Approval Inspection Readiness: Actionable Steps to Prepare for a BIMO Inspection - By Compliance Global Inc.

Overview:

Are you ready with your FDA audit preparation? An overview of the Compliance Program Guidance Manual for Investigational Sites and Sponsors for FDA audit readiness will be reviewed, as well as the BIMO inspection site audit checklist.

Why Should You Attend:

Attendees will learn what increases the risk of inspection, what types of inspections are conducted by BIMO, how to successfully prepare your site/facility and personnel, and how to interact with the FDA inspector.

Areas Covered in this Webinar:

When an inspection is likely to be scheduled
What types of BIMO inspections can be conducted
Become familiar with key FDA inspection terminology
What the FDA inspector will ask to see, and current trends in findings
Site inspection procedures
Sponsor inspection procedures

Learning Objectives:

Learn how to Identify key personnel and why it is important to have SMEs (Subject Matter Experts)
Strategies for successful interactions with a FDA Inspector

Who Will Benefit:

Regulatory Affairs Personnel
Regulatory Coordinators
Clinical Research Coordinators
Principal Investigators
QA/QC Staff

Speaker Profile:

Nicole began her career in Clinical Research over 17 years ago as a Clinical Research Associate for a small Clinical Research Organization. The “accidental” career that began after receiving her undergraduate degree has proven to be rewarding, challenging and continues to inspire her to do more and learn more in the field of Clinical Research.

Nicole has held roles such as CRA, Lead CRA, Project Manager, Regional Operations Manager, and Auditor.

In 2013 she started Harmony Clinical Consulting, providing consulting services to the pharmaceutical and biotech industries.