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Labeling Risk Management – Five Step Plan

Labeling Risk Management – Five Step Plan

By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of...
Adverse Event Reporting for OTC Drug Products

Adverse Event Reporting for OTC Drug Products

By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by...
PCQI Training: Is it worth it?

PCQI Training: Is it worth it?

by Elise Forward, EAS Independent Consultant I will admit to being biased on the many benefits of becoming your food firm’s Preventive Controls Qualified Individual (PCQI). It’s an important position, one required by FDA for ALL food manufacturing and warehouse...