Navigating the FDA OTC Monograph System
Presented by Lisa El-Shall
November 13, 2025 | 1 PM Eastern
Understand your product and the regulations that apply to it! This webinar will cover the FDA OTC Monograph system in detail. Topics include understanding what active ingredients are allowed and at what concentration in the finished product for a particular indication, permitted combinations of active ingredients, and labeling requirements for OTC drug products.
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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.