November 2020 - rfxcel.com
EnglishFrenchGermanItalianPortugueseRussianSpanish

Russia Reporting Update

rfxcel, the Leader in Russian Supply Chain Compliance, Quickly Adapts to Major Changes to Reporting Requirements

Russia’s Drug Circulation Monitoring System (MDLP) has developed new reporting requirements after experiencing technical problems that created serious issues in the country’s pharma supply chain. One of the most important changes is to Form 703, which facilitates foreign importation to Russia.

As the leader in Russian compliance, we acted immediately and now support the MDLP’s new transaction requirements. To learn more about the changes and how to comply with Russia’s strict track and trace requirements, contact Victoria Kozlova, rfxcel’s General Director in Moscow, at vkozlova@rfxcel.com.

DSCSA Guidance, Q&A Session, with Brian Files, DSCSA Strategic Advisor

Access webinar recording here

DSCSA Guidance and FDA explain the latest enforcements and changes in the regulation.

Do you have questions about the enforcement delay of the DSCSA? Not sure what this means for you?
Brian will answer your questions, explain exactly what you have to do to comply, and give insights into the DSCSA as we move into 2021.

Once registered, you will receive a confirmation email. Please note that given the nature of this session, we will rely heavily on your questions and how we can best serve you. Please let us know what you are wondering about by sending your questions to marketing@rfxcel.com or by bringing them with you to the webinar and simply entering them into the chat at any time during the call.

In the meantime, check out rfxcel’s latest blogs on this topic: FDA Delays Enforcement of DSCSA Saleable Returns Requirement and Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns.

Download DSCSA Guide here

About Brian Files:
Brian Files is rfxcel’s DSCSA Strategic Advisor and principal and founder of BBF Consulting, LLC, and an expert on the U.S. and international pharmaceutical and healthcare supply chain compliance. He has an M.B.A. from the University of Michigan and a B.A. from Cornell University.

We are looking forward to the opportunity to speak with you soon!

This webinar ended. Please click here to request the DSCSA Guidance and recording.

Serialização & Rastreabilidade Conforme o SNCM – ANVISA

 PT: Webinar ao vivo com Q&A: Visão Geral das Regras do SNCM – ANVISA, e Standards para Serialização & Rastreabilidade para Indústria Farmacêutica
Live Webinar with Q&A: Overview of the ANVISA Regulations, Industry Traceability & Serialization Standard
PT: Segunda, 7 de dezembro das 11:00 AM – 11:30 AM (BRT) 
Monday, December 7 from 11:00 AM – 11:30 AM (BRT)   
PT: Apresentado por: Vinicius Bagnarolli – Diretor – América Latina
Presented by Vinicius Bagnarolli – Diretor – América Latina
PT: Saiba mais sobre as últimas atualizações do Sistema Nacional de Controle de Medicamentos da ANVISA e como se preparar para atender a regulação
Learn about the latest information about ANVISA regulations and what is required from you. 
 
Registre-se aqui:
Register here:
https://attendee.gotowebinar.com/register/4489140361063737104
Para receber uma cópia da gravação, envie um email para latam@rfxcel.com
To receive a copy of the recording please email us at latam@rfxcel.com

Modernizing Food Recall Management

“Recall” is the one word food companies never want to hear. But recalls are a fact of life, so it’s the wise manufacturer, wholesaler, and retailer that prepares for the inevitable. What does it take to have fast, effective food recall management? The short answer is that you need to modernize your supply chain so you can act quickly based on high-quality data. Let’s take a look.

“Modernize” is today’s food and beverage buzzword

The Food Safety Modernization Act (FSMA) has been in effect for almost a decade, so modernizing the food and beverage supply chain isn’t a new idea. Designed to improve the security and safety of the U.S. food supply, FSMA focused on preventing food-borne pathogens across the food system. It also encouraged companies to be proactive instead of reactive when it comes to food safety — including how they deal with food recall management.

Now, the U.S. Food and Drug Administration (FDA) has ratcheted up its food safety efforts. On April 30, 2019, it announced the New Era of Smarter Food Safety, which it describes as “a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.” To be rolled out over the next decade, it’s “also about simpler, more effective, and modern approaches and processes.”

In other words, more modernization that builds on FSMA. The “ultimate goal is to bend the curve of foodborne illness in this country by reducing the number of illnesses.”

Then, in July 2020, the Administration released the “New Era of Smarter Safety Blueprint” that

“ … outlines achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. It outlines a partnership between government, industry, and public health advocates based on a commitment to further modernize our approach to food safety.”

The Blueprint also includes a Food Traceability Proposed Rule (formal title: “Requirements for Additional Traceability Records for Certain Foods.”) It would implement Section 204(d) of FSMA, with requirements to “help the FDA rapidly and effectively identify recipients of foods on its Food Traceability List to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death.” The list includes fruits and vegetables, fish, shellfish, cheeses, nut butters, eggs, herbs, and ready-to-eat salads.

What does modernization mean for food recall management?

It’s clear that FSMA and the New Era of Smarter Food Safety have recalls in mind when they mandate modernization or propose procedures to attain it. However, with or without the influence of regulations, rules, blueprints, and lists, modernization boils down to two things for food recall management: digitization and traceability.

A digital supply chain with end-to-end traceability delivers speed and high-quality data, the most crucial aspects of food recall management. Digitization — eliminating the physical paper trail in favor of a cloud-based management system — enables end-to-end traceability, and end-to-end traceability means you have rich, actionable data available in real time so you can find products quickly, make informed decisions, and act with authority and assuredness.

Digitization and traceability also expediate food recall management because they allow you to easily share information with your trading partners and regulators. If you’re a manufacturer or wholesaler, you’ll keep retailers up to date so they can take the recalled product off the shelves. Consumers benefit too, because they’ll get recall alerts and know to return the product or dispose of it as instructed.

Modernizing food recall management also helps mitigate the very things that can trigger a recall in the first place, such as poor visibility into the supply chain, lack of accountability, or an insufficient safety culture. Indeed, it’s up to companies to fix such shortcomings internally through training and establishing safety protocols, but digitization and traceability will carry and facilitate safety across the entire supply chain.

For instance, you can attach critical tracking events (CTEs) and key data elements (KDEs) to every product’s digital profile, creating an indelible provenance you can trace up and down the supply chain. You’ll see where a product has been, where it is (or is supposed to be), and where it’s going. During a recall, you can “reach into” your supply chain and extract the product quickly.

Final thoughts

As we move into 2021, F&B companies have absolutely no excuses to put off modernizing their supply chains and recall management systems. A poorly handled recall can result in catastrophic financial loss and cause irreparable damage to your reputation. And companies that don’t modernize will likely find themselves pursued by regulators, ostracized by trading partners, shunned by consumers, and, ultimately, out of business.

rfxcel can help. Our award-winning Traceability System (rTS) is the basis of a modernized, digital supply chain with fully customizable and scalable solutions that yield complete end-to-end traceability. It is the foundation of a digital supply chain and a successful food recall management system that operates with surgical precision.

For example, our Serialization Processing (rSP) solution assigns every product a unique digital ID that lets you locate affected products quickly, remove them from circulation, and record and verify that every recalled item was destroyed. Furthermore, rSP generates last-mile data that helps you identify the source of outbreaks and their scope for better consumer safety efforts.

Coupled with rSP, our Raw Materials Traceability (rRM) and Finished Goods Traceability (rFG) solutions build a digital supply chain that aids food recall management by maintaining a validated, traceable pedigree for every product. Track the transformation of raw materials into finished goods with total forward and backward traceability. Track lot to unit or unit to lot all the way to the consumer. Attach key data to every critical tracking event digitally. And if there’s a recall, see how exposed you are and respond rapidly by notifying affected customers and trading partners and changing the disposition of all units/lots to “RECALL” to prevent them from being included in any ship event. You can also use your data to aid investigations.

Contact us today to speak with one of our F&B supply chain experts. They’ll give you a short rTS demo that will show you how an rfxcel digital supply chain with end-to-end traceability will modernize your operations and optimize your food recall management.