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…

Last year 51% of U.S. food importers audited by the FDA failed - mainly due to an inadequate Foreign Supplier Verification Program (FSVP). Businesses that don’t comply with complicated FSVP regulations are putting themselves at risk of costly penalties and supply chain disruptions.   In this webinar, FSVP compliance experts Coley Anderson and John Kelly will…

This webinar will take you through an introduction of the requirements of 21 CFR 58, Good Laboratory Practices for Nonclinical Studies and give you valuable examples of why GLP is important in a lab setting while identifying if the regulation applies to you and your company. We will also give you key strategies for implementation…

Discover the essentials of Master Files (MFs) in the drug industry with our experts, Melissa Sayers and Megan Moore. Learn about which agencies utilize MF submissions, what are the common required documents, when fees apply, and the submission processes. We'll also cover electronic Common Technical Document (eCTD) submission, a common format for MFs, and how…

Você sabia que dois dos motivos mais comuns pelos quais os produtos alimentícios são proibidos de entrar nos EUA, são erros de rotulagem e aditivos alimentares ilegais? Muitas empresas não descobrem que seus produtos não são permitidos no mercado dos EUA até que seja tarde demais, e eles são detidos no porto. Qualquer empresa que…

Learn about the upcoming labeling requirements mandated by MoCRA as well as the general requirements all cosmetic products must meet. We describe in detail what must appear on your products’ labels and the timelines for compliance. 

Mit dem bevorstehenden Inkrafttreten des MoCRA am 1. Juli war es noch nie so wichtig wie heute, die neuen Vorschriften der US-amerikanischen FDA für die Kosmetikindustrie nachzu-kommen und unterhalten. Nehmen Sie an " Praktische Schritte, um schnell MoCRA-konform zu werden " teil, in dem wir Kosmetikmarken und -hersteller mit Wissen und Strategien ausstatten werden, um…

Tenuto conto dell’avvicinarsi della fine del periodo di “discrezionalità applicativa” decretata dalla FDA al 1° luglio prossimo, essere e rimanere in regola con i nuovi requisiti per la cosmetica diventa urgente. Partecipate al nostro webinar “Passi pratici per adeguarsi rapidamente al MoCRA” per acquisire le informazioni necessarie all’adeguamento normativo e alla definizione delle vostre strategie…

This webinar conducted by Registrar Corp with our cosmetic expert, Jaclyn Bellomo, shares key provisions of MoCRA that you must follow and provides insight into how they impact your business operations. Dive into the various challenges with product listings, navigating Cosmetics Direct, new adverse event requirements, and more.

Registrar Corp vi invita a partecipare al webinar "Requisiti FDA per i dispositivi medici negli USA ", organizzato in collaborazione con Ceipiemonte.

This webinar conducted by Registrar Corp and Amazon will provide businesses seeking U.S. expansion insights on navigating new FDA requirements enacted under the Modernization of Cosmetics Regulation Act (MoCRA) and will cover best practices for cross-border e-commerce solutions.

This webinar conducted by Registrar Corp and Amazon, will provide businesses seeking U.S. expansion insights on navigating FDA compliance and will cover best practices for cross-border e-commerce solutions.

Last year 51% of U.S. food importers audited by the FDA failed - mainly due to an inadequate Foreign Supplier Verification Program (FSVP). Watch our webinar to learn about FSVP best practices, common challenges that U.S. importers currently face, and tools to automate your FSVP compliance.

Did you know that two of the most common reasons food products are refused entry into the U.S. are labeling mistakes and illegal food additives? In this webinar, food safety expert Anna Benevente will cover critical labeling information you need to know before you ship.

In this webinar, we unmask the complexities behind the booming “clean beauty” trend and discuss the regulatory and legal pitfalls to avoid.

Discover how we can help you interpret the MoCRA regulations and develop a comprehensive compliance plan to help you provide safe products to your consumers.

Discover what requirements must be met under MoCRA for cosmetic facility registration and product listings.

Discover the Good Manufacturing Practice (GMP) basics, FDA's previous stance on GMPs, what GMP might look like under MoCRA, and how to prepare in the coming months.

Learn about the upcoming changes under MoCRA concerning Adverse Events for cosmetics, including the collection of Adverse Event consumer disclosures and reporting serious Adverse Events to FDA .

In this webinar, we gather industry experts to demystify the legislation and discuss how your business should prepare.

In this webinar, our industry experts delve into FDA's released draft guidance on cosmetic facility registration and cosmetic product listings with key definition updates and exemption clarification.

Considerati i cambiamenti significativi nel panorama normativo, è essenziale che i professionisti del settore siano informati. Unitevi a noi per scoprire come registrare correttamente la vostra azienda e i vostri prodotti presso la U.S. FDA.