Become MoCRA Compliant Today: [ Ссылка ]
Get In Touch with an FDA Expert: [ Ссылка ]
A Guide to Serious Adverse Event Reporting for Cosmetics: [ Ссылка ]
The Complete Guide to MoCRA: Cosmetics Regulations 101: [ Ссылка ]
MoCRA and Responsible Persons: A Guide: [ Ссылка ]
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Get your cosmetic businesses FDA compliant with the new regulations under the Modernization of Cosmetics Regulation Act (MoCRA). As a global leader in regulatory compliance serving 31,000+ clients across 190 countries, Registrar Corp helps companies become MoCRA compliant the right way with industry-leading professional services and software.
In this video you will learn about how FDA has expanded authority and regulatory power specifically for Adverse Events. FDA can now issue a Mandatory Recall if they determine that a cosmetic product is adulterated or that the exposure will cause serious adverse health consequences. They can also suspend a facility if there is reasonable probability of causing a serious adverse health consequence or public health concern. During inspections FDA can request information to help determine if the Adverse Events require a recall or to suspend a facility.
0:00 Introduction to Jaclyn Bellomo
1:49 Overview of new Adverse Event Requirements for Cosmetics
11:18 Requirements for receiving adverse events and upcoming deadline for cosmetic labels
22:52 Process and tips for implementation of an Adverse Event intake system
32:41 Adverse Event Management Software Demonstration
48:04 Q&A
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