• Food Safety is a Matter of Degree

    7 March, 2014 by Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    Global Food Safety Conference 2014 kicked off recently in Anaheim, California with a record-breaking attendance. It seems that everyone is concerned about the condition of the food they eat, if they have it to eat.

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  • Quality Event Management: Free Recorded Webinar Shows How a Closed-loop Methodology Can Improve CAPA Systems

    27 February, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Quality guru Ken Peterson has dedicated his career to helping organizations like Abbott Laboratories, Kodak, and IBM devise better quality management solutions that allow them to maximize efficiency and resolve problems faster. In the first of a three-part series of complimentary webinars available from MasterControl, Peterson breaks down quality management into three distinct segments: quality events, issue review, and corrective and preventive actions (CAPA). You can view the free webinar in its entirety here. No registration is required to access the recorded presentation—just click and play!

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  • Collaboration is More Than Just a Buzzword in Regulated Environments

    10 February, 2014 Marty Jackson, Professional Services Consultant, MasterControl Inc.

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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  • MasterControl's Murray & Knauer Guest Speakers at MD&M West

    5 February, 2014 Robyn Barnes, Public Relations, MasterControl Inc.

    If you’re working in the medical device industry, chances are you’ll be heading for MD&M West in Anaheim next week. MD&M West is the world’s largest medical OEM event.

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  • Where Are You in Your Quality Management Maturity?

    31 January, 2014 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    We’ve all heard about quality management journeys or trips down the quality lane. I heard someone recently equate quality to following the yellow brick road. Quality similes are usually about pathways but this week, I read a new description.

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  • How Dole Uses Technology and Proactive Food Safety Program To Save Time, Money

    27 January, 2014 Nye Joell Hardy, Senior Food Safety Manager, Dole Fresh Vegetables

    This article is based on a presentation the author gave at the FoodSafetyTech Conference on May 17, 2013 in Chicago.

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  • An Argument for Effective Quality Management Systems

    31 December, 2013 Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

    All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations. However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making. Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning. Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

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  • What If You Needed SOPs to Run Your Household?

    5 December, 2013 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    In August, I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s Digital Summit.  The presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into much more detail than our February blog post on the same subject (which you can read here:

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  • Three Common Issues Involving Clinical Trials

    24 October, 2013 Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

    In clinical research, there are two major regulatory concerns: patient safety and data integrity. While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.

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  • Elements of Effective Quality Agreements

    14 August, 2013 Steven Sharf, President and Principal Consultant, GMP Concepts

    Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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  • Building a Quality Plan for Implementing EN ISO 14971:2012

    14 August, 2013 Robert Packard, Regulatory Consultant, MedicalDeviceAcademy.com

    On May 16 of 2012, the European Committee for Standardization (CEN) approved a revised European National Standard for medical device risk management: EN ISO 14971:2012. There were no changes to the main body of the Standard (i.e. – Clauses 1 through 9). Instead, the revised European National (EN) version identifies seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the MDD, the AIMD, and IVDD respectively. Those seven deviations are:

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  • Quality Audit - A Tool for Continuous Improvement and Compliance

    18 April, 2017 Jason Clegg, Marketing Director, MasterControl, Inc.

    The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

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  • The 5 'W's of Quality Agreements

    18 April, 2017 Arvilla Trag, ASQ Certified Quality Auditor, Midwest Consulting Services, Inc.

    What is a Quality Agreement, and what should be included?

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  • FDA 21 CFR Part 11 And Predicate Rules Article

    14 April, 2017 David Ade

    Ten years after the FDA issued 21 CFR Part 11, the agency is expected to issue a new guidance for compliance, even as it considers revising the regulation.

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  • ISO Standards: Quality Objectives and Quality Dreams

    6 October, 2010 Mark Kaganov, Director of Quality Operations, Quality Works

    Author's Note: This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives

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  • Quality Inspiration: Six Quality Quotes for You to Consider

    5 April, 2011 Jennifer Stepniowski, Special Project Manager, Pro QC International

    I enjoy insightful prose...I enjoy reading it, thinking about it and sharing it with others. I think memorialized words of wisdom from others not only define the originator, but they also contribute to our individualism.

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  • The Odd Couple - Quality vs. Research

    29 February, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl, Inc.

    Compliance is often seen as a subjective word, and at best can mean something very different from one functional area to another within the same organization. The compliance requirements for a quality group are very different from those in R&D groups such as Clinical and Regulatory Affairs. Technology and processes can play a significant role in defining and meeting compliance requirements, however if the technology is not flexible and configurable it can become difficult to implement one solu

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  • Avoiding Human Error in Design

    14 August, 2013 BW (Ben) Marguglio, President, BW Marguglio, LLC

    Any enterprise that is engaged in activities with the potential for public and employee harm should be encouraged, if not required to develop and implement an integrated risk management, safety management, quality management and environmental management system for the prevention of events with intolerable effects. Such a management system would establish various techniques by which to analyze the safety and quality of the designs of hardware and processes.

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  • How to 'Sell' Quality

    30 October, 2012 Deborah Mackin, Performance Strategy Consultant, New Directions Consulting

    ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door.

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  • Quality Professionals: How to Increase Your Job Security

    31 January, 2013 Cindy Fazzi, Staff Writer

    The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

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