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.
Understaffed Restaurants and the Risk of Foodborne Illness
By Jayne Roth, M.P.H, REHS, EAS Independent Consultant At the end of 2021, a survey fielded by the National Restaurant Association, showed that 78% of operators said their restaurant did not have enough employees to support customer demand. Understaffing is not only an economic issue, but also a...
FDA Takes OTC Accelerated Stability Data Very Seriously
Did You Know?The FDA expects all drug products to bear an expiration date that is backed by scientifically sound data and projections, regardless of whether that drug is an NDA, ANDA or Over the Counter (OTC) monograph product. Under the FDA’s current expectations, OTC monograph drugs are provided...
The 12-Steps of Operational Efficiency
How Aligning of Operations and Quality Assurance Can Drive Down Costs While Improving Efficiency. Presented by Mike Hughes and Steve Cammarn, Ph.D., EAS Independent Consultants. Operations and Quality Assurance departments often operate in opposition. Their different goals lead to different...
Drug and Device Corner March 2022
FDA announced the fiscal year 2022 OTC-Monograph Drug User Fee rates in the Federal Register Vol 87, No 51 published today 16 March 2022. These fees cover FDA’s FY2022 which runs from October 2021 through September 2022. The facility fees for FY 2022 are due on 1 June 2022 Regarding fee specifics,...
Selecting a CRO – an Important Consideration on the Path to Determining GRAS for a Food Ingredient
By Shawna Lemke, EAS Independent ConsultantThe noble pursuit of ensuring food safety is as old as time. Historians find evidence as far back as ancient Egypt and Rome of dietary laws, labeling and inspections put in place at least in part to address food safety. In the US, concerns about...
Cannabis 2.0 – Avoiding Recalls with Shelf-Stability Testing
How cannabis 2.0 product makers can avoid expensive recalls with shelf-stability testing Cannabis 2.0 flooded online stores and retail shelves with exciting new items like infused beverages, chocolates, gummies and topicals. And while there are numerous regulations dictating the packaging,...
FSPCA Preventive Controls for Human Foods, Part 2 of Blended Course
Presented by Omar Oyarzabal, Ph.D. Senior Consultant. June 13-14, 2022 from 1-5pm easternThis course is for food manufacturers that need to complete Part 2 of the Blended Class on Preventive Control for Human Food. This online class will be delivered in two days of live, video conferences, from 1...
Medical Device Product Risk Management
Presented by John Lincoln, EAS Independent Consultant. 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 though many are still not developing...
Navigating the Process of Importing Food Products into the United States
Presented by EAS, Certified Laboratories and L&L Trade Law. Importers 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. Importers can import foods into the...
Drug and Device Corner February 2022
FDA’s New Draft Rule: “Medical Devices; Quality System Regulation Amendments” On February 22, 2022, FDA published a proposed rule that aims to harmonize the current Quality System Regulation for Medical Devices under 21 CFR part 820 with international standards, ISO 13485:2016, Medical devices –...
Are We Even on the Same Team?
Aligning Operations and Quality Drives Down Costs While Improving Efficiency By Mike Hughes, EAS Independent ConsultantHave you ever felt like your co-workers are at a different company? Maybe, even a competitor who is trying to run you out of business? Yup – I have. I am an Operations guy and the...
Internal Audits: Keys to Success
Presented by Susan Moyers, Ph.D., MPH, EAS Independent ConsultantMay 17, 2022 at 12-3pm easternAn internal audit can be a sensitive undertaking. Auditors are asked to assess the process performance of peers, and at times, superiors in the organization. A comprehensive internal audit can help...
How To Be an Effective and Sought After Expert Witness
As highly regulated industries are subject to more claims and litigations, and with growing agency challenges to ingredients, processes and branding, the target company’s regulatory compliance is often a key issue in presenting a successful defense. An expert witness’ opinion, report and testimony...
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...
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)...