EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
The Challenges of Controlling Heavy Metals in Baby Food: Operations, Regulations, & Testing
Food Safety & Quality teams across food industry segments are often tasked with ensuring raw ingredient integrity without impacting production timelines. This balancing act has become even more challenging considering increased product demand, pandemic-related disruptions, and growing...
Blended Learning – Part of a Culture of Learning
By Nancy Higley, EAS Independent Consultant Continuous learning supports both business and employee goals. When you hire an employee, you are hiring an asset capable of continuous growth. An educated professional can be a point of difference for your business. There is no one solution for Learning...
EAS Consulting Provides Keynote Address at AFIA
EAS consultant Carolyn Kennedy provided the keynote address at the American Feed Industry Association (AFIA) conference during the International Production and Processing Expo (IPPE) in Atlanta. Speaking on human grade pet food, she discussed submissions, labeling, and the future of the industry....
Drug and Device Corner January 2022
Reminder: CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 For application holders filing eCTD submissions via ESG, please...
CTP’s Draft Guidance on Analytical Testing Methods Validation and Verification for Tobacco Products
What You Need to KnowPresented by Charlotte Peyton, EAS Independent Consultant February 10, 2022 at 12-2pm easternFDA’s December 2021 draft guidance on validation and verification testing methods used in analytical testing of tobacco products creates an opportunity and defined mechanism by which...
U.S. FDA’s Latest Requirements for the 510(k)
Presented by John Lincoln, EAS Independent Consultant April 19, 2022 at 1pm easternThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval...
Navigating the Process of Importing Food Products into the United States
Presented by EAS, Certified Laboratories and L&L Trade Law February 24, 2022 at 1pm easternImporters of food products intended for introduction into the U.S. interstate commerce are responsible for ensuring that the products are safe, sanitary, and labeled according to U.S. requirements....
EAS Announces Omar Oyarzabal, Ph.D. as the New Senior Consultant for Food Services
EAS is pleased to announce Omar Oyarzabal, Ph.D. as a new senior consultant for Food Consulting Services. Dr. Oyarzabal, a long-time consultant with EAS, begins this new role today. As a senior consultant, he will work directly with EAS’ Senior Director for Food Consulting Services to assure...
Ensuring Quality Systems for Cannabis Manufacturing
A C-45 Webinar presented by Labstat and EAS Consulting GroupJanuary 11, 2022, 3pm easternCannabis business owners can benefit from the development and implementation of Quality Systems for the manufacture of their products including a higher quality product and more efficiency in overall...
Roles and Responsibilities for Ensuring the Safety of Animal Food
By Johnny Braddy, DVM, MPH, Dipl. ACVPM, EAS Independent Consultant. (This Issue of the Month article is an abbreviated version of a White Paper published on the EAS website.). To help ensure that the nation’s food supply is safe, Congress amended the Food Drug & Cosmetic Act (FD&C)...
Your Cannabis Business is Only as Strong as the Weakest Link in Your Supply Chain
Product consistency is the most important factor in achieving the holy grail of product manufacturing: return customers. Yet, too many companies are producing inconsistent products due to their lack of insight into their own supply chains. Running the risk of invoking the costliest mistake of all,...
Roles and Responsibilities for Ensuring the Safety of Animal Food
Prepared by Johnny Braddy, DVM, MPH, DACVPM, EAS Independent Consultant December 2021
Medical Device Product Risk Management
Presented by John Lincoln, EAS Independent Consultant February 28, 2022 at 1pm eastern Both the U.S. FDA and the EU's MDR require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits...
Drug and Device Corner December 2021
REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines Reports for calendar year 2020 should be submitted no later than 15 February 2022 Reports for calendar year 2021 should be submitted no later than 16 May 2022 Cover Letter Attachments for Controlled Correspondences and ANDA...
FDA Issues Draft Guidance on Validation and Verification of Analytical Testing Methods Used for Tobacco Products
On Dec. 21, FDA issued draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test...
FDA Issues Final Rule for Laboratory Accreditation for Analyses of Foods
The U.S. Food and Drug Administration (FDA) has issued a final rule establishing the Laboratory Accreditation for Analyses of Foods (LAAF) program as required by the FDA Food Safety Modernization Act (FSMA). This LAAF program recognizes accreditation bodies that accredit food testing laboratories...
Preparing for TMPs
Are You Ready for TPMPs? EAS Senior Director for Dietary Supplements and Tobacco Services, Tara Lin Couch, Ph.D., discusses expectations for FDA’s TPMPs and how your company can prepare. Contact EAS for assistance with all of your regulatory needs. Download our quick reference service information...
EAS Senior Director, Tim Lombardo, Is NIE’s Consultant of the Quarter
Tim Lombardo was interviewed in Nutrition Industry Executive as their consultant of the quarter. Tim discusses what makes EAS unique and how the merger of the Certified Laboratories Group of companies and FSNS is a great partnership. Read more.
Dairy Processing 101
A Virtual Training Presented by EAS Consulting Group and FSNSPresented by EAS Independent Consultants, Allen Sayler, Gabe Miller, Dave Blomquist, and Rhaisa A. Crespo, Ph.D.Coming SoonFebruary 15, 17, 22 & 24, 2022From 12:00pm-3pm eastern each dayThe FDA’s Food Safety Modernization ACT (FSMA)...
EAS Welcomes Maged Sharaf, Ph.D. as Senior Director, Labeling, Cannabis and Claims Consulting Services
Alexandria, VA: EAS Consulting Group is pleased to welcome Maged Sharaf, Ph.D. to the management team. As Senior Director, Labeling, Cannabis and Claims Consulting Services, he will be responsible for managing and providing label review and claims substantiation consulting services for...