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.
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.
Sayler and Couch Discuss Importing Challenges for Dietary Supplements Under FSMA and FSVP
EAS Senior Directors Allen Sayler and Tara Couch, Ph.D. discussed importing challenges of dietary supplements, particularly in light of the Foreign Supplier Verification Program in Food Safety Magazine. Dietary supplement firms must comply with GMPs set forth in 21 CFR 111 Current Good...
Independent Consultant Angel Suarez Covers Food Code Guidelines
Angel Suarez was interviewed on GMPs and Food Code 2017 Guidelines in an article published in Food Safety Strategies. In the food area, the GMPs ensure that ingredients, products and packaging materials are prepared, presented and handled safely and that food products are prepared in a suitable...
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.
Compliance with Mobile Medical Devices Discussed in MedTech Intelligence
Device companies seeking to develop products that include a mobile app must ensure regulatory compliance with product and data safety.
Top Five Hurdles for FDA ANDA Submissions and Approvals
By Radhika Rajagopalan 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....
Couch Authors Article on GLPs for Dietary Supplement Contract Labs
Supplement brands that partner with contract labs must ensure they are following good lab practices and other quality assurance programs.
Did You Know? The FDA Uses DUNS Numbers to Verify Company Information!
Data Universal Number Systems, commonly known as DUNS are unique, site specific, nine-digit identification numbers provided by Dun & Bradstreet (D&B) and used globally. Free to obtain, FDA and other federal agencies use DUNS numbers to track and verify company name, address, phone number,...
January 2020 Drug and Device Corner
Is your labeler code up to date?!? Chances are if you have not thought about this file since you originally requested a labeler code from the FDA, it could use an update. We saw during the drug listing certification period, that several labeler codes were reflecting outdated information. Keep in...
Couch Co-Authors Article in FDLI Update on PMTAs for Deemed Products
In October the FDA Center for Tobacco Products (CTP) held a Public Meeting about Preparing Marketing Applications for Deemed Products. A summary of that meeting was co-prepared by Tara Lin Couch, Ph.D. and published FDLI Update magazine.
Steve Armstrong Interviewed on Marketing Claims
Consumers demand certain qualities—think clean label, zero sugar and non-GMO, for example, and marketing claims can affect the ways that foods and beverages are produced.
Comprehensive Equipment Utility Change Control GMP Production Facilities
Tablets and Capsules January 22, 2020 https://tabletscapsules.com/article/comprehensive-equipment-utility-change-control-gmp-production-facilities/ Greg Weilersbacher
How Food and Beverage Marketing Claims Can Affect the Production Process
Food Engineering January 17, 2020 https://www.foodengineeringmag.com/articles/98672-how-food-and-beverage-marketing-claims-can-affect-the-production-process Steve Armstrong
Codex Opportunities for Food Manufacturers
Can Codex food standards and various food safety, hygiene guidelines and codes of practice positively impact domestic food manufacturers that do not export? The short answer is “YES!” Codex provides a transparent international platform for food safety and hygiene as well as manufacturing practices, food …
Developing a Mobile Medical Device? FDA Is Watching
MedTech Intelligence January 6, 2020 https://www.medtechintelligence.com/column/developing-a-mobile-medical-device-fda-is-watching/ Amy Scanlin
When you Need an Expert – Ask EAS!
In this month’s Ask the Expert column, we thought we’d start this new year by taking the opportunity to humbly share why we at EAS are confident that our staff and consultants offer the best expert regulatory knowledge in the industry, providing proactive and accurate solutions to your most...