How to Respond to an FDA Inspection (483)

Presented by Lisa El-Shall

November 20, 2025 | 1 PM Eastern

Now that the FDA has issued your firm a 483 or Warning Letter, what to do next? This webinar will cover the expectations and requirements of the FDA for responding to inspectional findings, best practices, and tips for creating a comprehensive response, including corrective and preventive actions taken and planned to address the observations.

Highlights include:

• Response content – ensure the response comprehensively addresses each finding.
• Realistic due dates – be careful not to overcommit!
• Tips for continued communication with the FDA and follow up.

About the Presenter

Lisa El-Shall

Senior Director for Pharmaceutical and Device Consulting Services

Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.