Introduction to FDA’s Cosmetics MoCRA Regulations
The FDA’s Modernization of Cosmetics Regulation Act (MoCRA) enforcement will impact your company. Built by industry and compliance experts, this 8-course library trains you on the new FDA requirements for Facilities Registration, Product Listing, Adverse Events Reporting, Good Manufacturing Practices, and much more.
Overview
This set of courses includes the following. You may take one or all and receive a training certificate for each one completed.
- Facility Registration and U.S. Agent Responsibilities
Understand who must submit a facility registration and who needs a U.S. Agent. Learn how to prepare as a responsible person and how to prepare for FDA inspections. Gain insights into the timing and requirements, what exemptions may apply, and how the facility registration requirement could affect other establishments. - Cosmetic Product Listings and the Responsible Person
Get an overview of existing cosmetic labeling requirements and a detailed explanation of new requirements added under MoCRA. Understand what makes a compliant label and how to prepare for the requirements as a responsible person. - Adverse Events & Safety Substantiation
Learn the requirements for adverse event reporting and record-keeping, what it means for large and small businesses, and how to prepare to meet these requirements. Learn who is responsible for safety substantiation, what will be required, and how best to prepare. - Good Manufacturing Practices (GMP)
Learn the basics of GMPs, what GMP compliance under MoCRA looks like in the coming years, the timing, who will be responsible for complying with the requirements, and how to begin preparations. - Registration and Listing Portal
Learn about the FDA’s electronic submissions portal. - Adverse Events & Safety Substantiation
Learn the basics of requirements for adverse event reporting and record-keeping, what it means for large and small businesses, and how to prepare to meet them. It also covers cosmetic safety substantiation, specifically, who is responsible for safety substantiation, the requirements,s and how to prepare. - Fragrance Requirements
The course covers fragrance allergen disclosures, how to prepare as a responsible person, what information to request from suppliers, and how to be prepared in the case of adverse events due to fragrance and flavor ingredients.
Instructor
Jaclyn Bellomo, our Director of Cometic Science and Regulatory Affairs, is a cosmetic industry professional with over a decade of experience in technical formulation, regulatory compliance, product development, and brand management. She has a Bachelor’s degree in Chemistry from Manhattan College, an MS in Cosmetic Science from Fairleigh Dickinson University, an MS in Regulatory Affairs from Northeastern University, and an MBA from Northeastern University. Jaclyn has worked with multinational brands, specializing in formulations for the beauty and personal care industry from concept to counter.