• Top 5 Up-and-Coming Trends for Nutraceuticals in 2018

    10 April, 2018 by Sarah Beale, Staff Writer, MasterControl

    Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. The industry has expanded its focus to not just provide natural, clean products but also innovative, high-quality ones. The five biggest trends for 2018 reflect this, bringing new steps and creativity to the product development process.

    Full story
  • Required Records of Selected Regulations Under the Food Safety Modernization Act

    20 June, 2017 by Erika Miller, Food Safety Specialist, D.L. Newslow and Associates

    The Food Safety Modernization Act, or FSMA (2011), has dominated the conversation in food safety circles for quite some time now. Compliance dates are arriving, and companies are realizing there is a lot to be done to become compliant. Companies that traditionally had little to no contact with the FDA (if everything was going right) are now seeing activity, whether anticipated or not.

    Full story
  • The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

    16 May, 2017 by Maile Gradison Hermida and Brian D. Eyink, Hogan Lovells US LLP

    With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare

    Full story
  • What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

    20 April, 2017 by Bryan Armentrout , CEO, The Food Leadership Group

    Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

    Full story
  • Supplier Approval Challenges Under FSMA

    1 March, 2017 Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

    Full story
  • Coming Soon to a Pharma Inspection Near You: The Program Alignment Group (PAG) Plan

    19 April, 2016 Mark Schwartz Of Counsel, Hyman, Phelps & McNamara P.C.

    There have been at least four FDA initiatives, in the works for some time that, in the coming years, will change the way pharmaceutical (and indeed all FDA) inspections are conducted. We think you should know about these initiatives, and how they are likely to affect the way companies prepare for, and deal with, FDA inspections. Today, we are going to discuss the Program Alignment Group (PAG) plan, arguably the least controversial of the four. Over the next few weeks we will discuss the other three programs that are likely to dramatically affect the inspection landscape.

    Full story
  • What Is a Food Safety Plan and What Is It Doing on My Table?

    22 September, 2015 W. Lynn Hodges, HACCP Consulting Group, LLC

    Whenever you go out to eat with your family, co-workers, or friends, you may be unaware that many of the restaurants (food service establishments) and retail food stores have some type of food safety plan in place. Most of the chain restaurants have sophisticated food safety systems designed and implemented for their daily operations and as well as many of the larger, more established restaurants and retail food stores. The U.S. Food and Drug Administration encourages these retail food operations to implement food safety systems and use them throughout the everyday activities of the operations.

    Full story
  • Why Food Makers Are Investing In Food-Safety Software

    16 October, 2014 Sam Lewis, Associate Editor, Food Online

    Throughout 2014, food makers have put forth significant efforts in pursuit of food-safety and quality-management software solutions. But why is there so much interest and effort in these systems now?

    Full story
  • Certification: Is It Worth the Hassle?

    12 August, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.

    Full story
  • Strategies for Addressing the Top 3 Quality Pains in a Regulated Environment

    8 May, 2014 by Paul Sanderson Lead, Solutions Consultants Group, MasterControl Inc.

    In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.

    Full story