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.
Process Validation for OTC Liquids and Topical Products
Presented by EAS Independent Consultant, Miguel MontalvoDecember 9-10, 202012:00–3:00pm EasternIf you manufacture OTC liquids, such as hand sanitizers, and other topical products, an effective Process Validation Program is an FDA requirement. Do you have a robust Process Validation Program at your...
Developing Quality Systems for the CBD and Hemp Industries – EAS Short Course
As states begin to regulate legalized CBD and hemp, the concern of how Good Manufacturing Practices (GMPs) apply to these unique industries cannot be understated. While regulations vary from state to state the quality systems under which products are grown …
Hygiene Improvement, Monitoring & Tracking
While the “new norm” for food manufacturing hygienic practices is rapidly evolving, an intense focus on proactive assurance of food and employee safety is the top industry priority. With increased focus on hygienic practices comes an increased requirement to data …
Understanding and Mitigating Risks of Emerging Pathogens
The food industry has a history of testing for Enterobacteriaceae, coliforms and/or E. coli as indicator microorganisms. Since 2009 there were 40 outbreaks in the United States of pathogenic E. coli such as Shiga toxin-producing E. coli (STEC) associated with leafy greens…
Did you Know? EAS Assists with California Prop 65 Requirements
Proposition 65 requires specific warnings be applied to products sold in California that contain any one of the ~900 chemicals on the Proposition 65 list, whereby use of the product results in consumer exposure to those chemicals above Safe Harbor Levels. EAS is a regulatory partner helping firms...
Maintaining Compliance through Virtual Audits
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead…
Cleaning-In-Place (CIP) Validation
“Validation” is a term and concept that is widely used but is also widely misused and misunderstood. Validation of food safety control measures is currently a mandatory requirement in US, other countries and in internationally accepted regulations, but also in GFSI certification schemes, i.e. SQF, BRC, FSSC22000 and IFS. Several FDA and USDA regulations including FSMA Preventive Controls, LACF/AF…
Did You Know? EAS Offers USDA Consulting Services, Including Labeling Assistance and Organic Requirements
EAS independent consultants include experts in USDA regulations. From the unique requirements of USDA labeling to food safety of domesticated meat products and shell egg products, you can be confident that EAS offers accurate and thorough advice and actionable compliance plans in accordance with...
EAS Authors Chapter in Present Knowledge in Nutrition 11th Edition Published by Elsevier
Just released on July 31, 2020, EAS Independent Consultants Betty Campbell, James Hoadley, Ph.D. and Robert Post, Ph.D. co-authored an article on Nutrition in Labeling including topics such as mandatory and optional nutrition label information in specified formats and optional nutrition-related...
Hygienic Equipment Sanitation – Best Practices for Food Safety
This short course offers practical information on best practices, “real-world” examples and tips on how to enhance daily operations related to improving existing food safety and quality programs. The three-session training will focus on criteria for selecting, installing and maintaining processing …
Cell-Cultured Meat Products and Plant-Based Protein Analogues
An EAS Consulting Group White Paper discusses regulatory aspects and consumer trends in cell-cultured meat products and plant-based protein analogues.
As consumer acceptance …
Selecting and Submitting an ANDA Application
The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until …
Retail Food Safety in a Post-Pandemic World
The Retail Food Industry is finally beginning to see an opening as many areas of the country are experiencing decreasing cases of COVID-19, meaning businesses can begin to safely scale up. But what does that mean and how can the retail food industry ensure safe operations in this new normal? Do you understand …
Did You Know? EAS Helps Firms Prepare for FDA Inspections Against Intentional Adulteration Rule
FDA began inspections for Intentional Adulteration (IA) Rule components in March 2020, including assessment of Food Defense mitigation strategies, verification of effectiveness and the development of corrective action steps to be taken in the event that the mitigation strategy was not implemented...
Allen Sayler Receives IAFP Honorary Life Member Award
EAS is pleased to announce that Senior Director for Food Consulting Services, Allen Sayler, has been awarded the prestigious International Association of Food Protection (IAFP) Honorary Life Member. This award, through nomination by industry colleagues, recognizes Allen’s career achievements and...
Reality Due to Globalization
The year 2018 witnessed the 100th anniversary of the influenza H1N1 pandemic, sometimes referred to as the 1918 Spanish Flu. Despite being coined the Spanish Flu, its origins are unknown. That pandemic, which killed an estimated 50 million worldwide and 675,000 in …
Writing Effective SOPs Can Influence Compliance
EAS independent consultant, Heidi Stuttz discussed how writing effective SOPs can influence compliance and build a better organization in Drug Development Delivery. Drug firms must devote time, diligence, and meticulousness in the development of safe product design, materials …
New On-Demand Webinar – OSHA Employee Safety Requirements of Lockout-Tagout
If you missed the EAS webinar covering the critical steps to the life-saving Lockout-Tagout, the complimentary webinar is now available on-demand on the EAS website. Understand the steps to safely disable equipment in need of repair and maintenance as well as OSHA’s requirements for employee...
Did you know? EAS Offers Submission Support for CDER eCTD Applications
Did you know there are exemptions/waivers for FDA’s eCTD requirements for CDER applications? In February 2020, the FDA released a Guidance Document regarding eCTD requirements for regulatory submissions. This guidance document describes how content must be organized in order to be submitted to the...
Unique Device Identifiers – Are Your Products in Compliance?
EAS reminds all medical device firms that the compliance date by which devices must have a UDI is approaching. For more details on this requirement we invite you to read an EAS authored article in MedTech Intelligence. Timely compliance will ensure that your products will not be considered...
Sensory Considerations for Reformulating Food Products with Reduced Sugar and Sodium
Former EAS Consulting Group Independent Consultant, Rebecca Harter, discussed sodium and sugar reduction considerations in an article published in Natural Products Insider. Whether reduction is achieved by direct replacement, lowering formulation levels or the utilization of other ingredients for...
Active Managerial Controls for Food Safety – On-Demand Webinar
EAS independent consultant and former CDC Environmental Health Officer / Deputy Chief, Charles Otto, presented a webinar for the National Restaurant Association on Active Managerial Controls for Food Safety. AMCs are a great enhancement to Food Code-compliance procedures. Contact EAS for all your...
Fast Tracking Antimicrobial Agents – FDA’s Accelerated Programs
Developers of antimicrobial agents may seek an accelerated FDA review of their products under the accelerated programs such as Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, or Priority Review and gain additional 5 years of …
OSHA Lockout-Tagout – Critical Steps to Employee Safety
Is your manufacturing floor a safe work environment? Do you abide by OSHA controls commonly known as Lockout-Tagout? Employees can be seriously or fatally injured when machinery they clean, service or maintain unexpectedly energizes, starts up, or releases …
Building Food Product Development Branding and Messaging
Food companies are striving to be a force for good and today many are developing products to accelerate wellness. That’s because consumers are prioritizing health consciousness as part of their everyday food choices, according to the IFIC Foundation 2019 Food and Health Survey. Price, taste and convenience are no longer the reigning factors. And, for many consumers, a food label alone is not sufficient to convey the information they seek to make a choice. Consumers are weighing a new set of factors and choosing food and beverage products that promote their health and wellness. To that end, food manufacturers must ensure that their business functions and product messaging convey integrity of brand, promotes transparency, and are messaged beyond the label to be appealing.
Cutting Edge Methods for Detecting Food Fraud
The challenge of detecting Food Fraud has never been greater nor the economic loss to food manufacturers, importers, retailers and consumers. In the recent past, we have had to rely on the integrity of the supply chain, person to person relationships and trained sensory
Therapeutic Nutrition: Potential and Challenges for Novel New Products
David Cockram, Independent Consultant, EAS Consulting Group, LLC We live in exciting times, with new discoveries being announced daily about the relationships between nutrition, diet, health, and disease. So much so that it’s often hard to keep track of whether this food or food component is...
Did you Know? Requirements for Animal Food/Feed Manufacturers Include Preventive Controls
Preventive Controls for Animal Food/Feed is a requirement for all manufacturers of animal food/feeds. EAS expert, Jerry Poley, who assists clients with food safety audits including requirements for HACCP, FAMI QS, FPA Safe, PAACO (Professional Animal Auditor Certification Organization) as well as...
Tips to Streamlining the Drug Master File Process
The meticulous detail of a Type II Drug Master Files (DMF) enables FDA to review and assess the chemistry, manufacturing, stability, purity, impurity profile, packaging and Good Manufacturing Practices data of Active Pharmaceutical Ingredients (API) or a finished drug dosage form …
Greg Weilersbacher on Change Control for GMP Production Facilities
Many companies limit change control to documentation while handling equipment and facilities in isolation, but that practice can wreak havoc on GMP operations.