Adverse Event Reporting for Cosmetics in the US Market: Addressing Serious Incidents and Reporting to the FDA

20,00 excl. VAT

Category:

Description

In this 45-minute webinar, our speaker will provide an overview on the new MoCRA requirements on cosmetic adverse events in the US market. Watch the video to know on how to be ready by the deadline: December 29, 2023.

Agenda

    • Cosmetic Industry Roles under MoCRA: Obligations of Brand Owners, Formulators, and Manufacturers
    • Managing Adverse Events for Cosmetic Products: How to Receive, evaluate, and address adverse incidents related to your products 
    • Reporting Serious Adverse Events to the FDA
    • FDA inspections of adverse event records
    • Q&A

Speaker

Geoff Waby – Obelis USA Board of Directors

Geoff Waby has more than 35 years of experience in Quality Assurance and Regulatory Affairs covering OTC drugs and cosmetics. He was the quality assurance lead for Procter & Gamble in Europe, the Middle East, and Africa, before holding the same role for Estée Lauder, firstly in Europe, followed by North America. Geoff served on committees with Cosmetics Europe and is an active member of the Personal Care Products Council. He is co-chair of the PCPC Manufacturing Hygiene task force and an adjunct instructor at the James L Winkle College of Pharmacy, University of Cincinnati. Geoff is an expert in the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).

Silvia Zarzuela Martin – Obelis Business Development Department

She is a Junior Consultant in the Business Development Department at Obelis Group. Silvia leverages partnerships with other entities and takes part in a wide variety of projects supporting corporate buildout.

 

Published on September 20, 2023