Welcome to the February 2019 edition of EAS-e-News, the free news publication dedicated to FDA regulated industries. I’d like to begin by bringing your attention to our many new educational opportunities. From our many complimentary webinars to regulatory compliance seminars EAS brings the best in regulatory education to you through our extensive network of independent experts. In this issue, you’ll find numerous opportunities to learn in real time in addition to our wealth of on-demand webinars available for viewing at your convenience.
On that note, two recent additions to our complimentary webinar offerings include one on the requirements for Qualified Individuals, hosted by Independent Advisors Domenic Veneziano and Charles Breen, and regulatory challenges and opportunities for companies preparing New Infant Formula Notifications, presented by EAS Independent Advisor Robert Martin, Ph.D., and Independent Consultants Robert Burns, Ph.D. and Timothy Morck, Ph.D.. More information can be found in the EAS in Action section of this issue.
Our Issue of the Month is written by Independent Advisor for FSMA, Charles Breen, and discusses two very similar sounding terms, Qualified Individual and Preventive Controls Qualified Individual, which have two very different meanings. Our Ask the Expert is written by James Hoadley, Ph.D. and discusses the provision in the recently signed Farm Bill which covers “added sugars” and when the “includes X g added sugars” can be omitted from a label.
Also in this issue, we introduce a new section called “Did you Know?” which will provide a brief spotlight of concern to FDA
Further, EAS has just released our newest Video Short, on cannabis quality issues and how EAS Consulting Group can help companies navigate as the industry pushes for for developing sound Good Manufacturing Practices.
Lastly, we are so pleased that there is at least a temporary solution to reopen the federal government after the longest shutdown in our nation’s history and we hope for a lasting resolution that enables both sides of the aisle to find common ground. The shut down has had numerous negative impacts, including severely curtailing operations at FDA and USDA, are we are thankful, at least for the moment, that our federal employees are able to get back to the business at hand by serving the public.
Thank you as always for your interest in EAS and EASeNews. You are one of the 16,000 who receive our newsletter and we take great pride in bringing you relevant content and compliance solutions. Please let me know if you have any questions on this issue or other areas of FDA compliance.
Chairman and CEO