Issue of the Month
Regulatory insights from EAS Consulting Group consultants.
Each month, EAS Consulting Group publishes an Issue of the Month examining emerging regulatory developments, compliance challenges, and quality system insights across FDA-regulated industries.
These articles are written by EAS consultants and industry specialists with decades of experience supporting companies in food, dietary supplements, pharmaceuticals, medical devices, tobacco, and related sectors.
Topics frequently explored include food safety systems, inspection readiness, regulatory strategy, and emerging industry risks such as why food recalls are increasing.
New this month
Featured Insight
Artificial Intelligence: Quality Friend or Foe
This Issue of the Month explores how artificial intelligence is being applied in regulated industries, examining potential benefits for quality and compliance programs while highlighting risks and considerations companies should evaluate before integrating AI into regulatory operations.
Archive of Past Issue of the Month Regulatory Insights
Genome-Edited Crops and the National Bioengineered Food Disclosure Standard: Can Regulators Find the Right Balance?
Anyone who follows science news has probably heard of the phenomenal scientific advancements using CRISPR. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) exist in nature as a defense mechanism in bacteria against invading viruses. In 2012, researchers Jennifer Doudna and
New Ingredients in Pet Food Formulation: Not as easy as creating a product with a few trending ingredients
By Carolyn KennedyEveryone...
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…
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 …
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.
Therapeutic Nutrition: Potential and Challenges for Novel New Products
David Cockram, Independent...
Top Five Hurdles for FDA ANDA Submissions and Approvals
By Radhika Rajagopalan The...
FDA Cites Multiple Violations for Selling CBD as Supplement, Food, Cosmetic or Animal Food Ingredient
By Gisela Leon, MS, MBA,...
Equipment and Utility Change Control for GMP Production Facilities
By Greg Weilersbacher...
GRAS Determination: Lessons and Pitfalls
By Tom Jonaitis Over the 14...
Avoiding Delays of Your Import Cargo Shipments through US Customs and Border Protection (CBP)
By William (Bill) Scopa The...
What are SDSs?
By Robert Kapp, Ph.D. Safety...
Challenges with Implementing Cleaning Validation
By Miguel Montalvo Though...
Big Data, Real World Evidence and The Digital Revolution – Hang On!
By: John Brennan Executives...
Preparing For a FDA Preventive Controls Inspection
By Joe Famiglietti The new...
Will FDA Suspend Your Food Facility Registration Based on Environmental Results?
By Kathy Knutson, Ph.D. In...
Qualified Individual and Preventive Controls Qualified Individual – What’s the Difference?
By Charles Breen The Food...
Dietary Supplement Specifications Development – Still Challenging the Industry Ten Years Later
By Tamika Cathey...
Four Common Mistakes When Selecting a Rapid Method for Environmental Testing
By Bryan Armentrout We are...








