• Things Change - Plan On It

    Denise Robitaille, RABQSA-certified lead assessor, ASQ-certified Quality Auditor and Fellow of the American Society for Quality

    This article was originally published by Quality Digest Magazine.

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  • Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

    19 April, 2017 Mike Micklewright, President of QualityQuest Inc.

    This article originally appeared in "Quality Digest Daily," an electronic publication from Quality Digest (www.qualitydigest.com)."

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  • Reading the FDA Tea Leaves

    7 December, 2011 John Avellanet, Management Director, Cerulean Associates, LLC

    Adapted from Cerulean's regulatory intelligence monthly newsletter, SmarterCompliance™ (No. 48, Vol. 4, Iss. 12).

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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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  • Quality Basics Simplify Complex Engineering Document Management Challenge

    6 October, 2010 Ted Shaar, Freelance Writer on Quality Topics

    This article was originally published in ASQ.

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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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  • Implementation of the Food Safety Modernization Act

    12 July, 2011 Cathy Crawford, HACCP and Food Safety Expert

    As of July 3rd, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record keeping practices.

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  • Top Benefits of Electronic GLP Management: What Non-Clinical Research Laboratories Should be the First to Know

    Diane Clements

    Industrialized nations, such as the United States, the European Union and Japan, have increasingly aging populations and are experiencing unprecedented growth in demands for healthcare and related technologies.

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  • Product Development and Clinical Data Quality Management


    The product research, development and approval road is long, arduous, and costly, especially for pharmaceutical companies that are still reliant on manual processes and paper-based systems.  According to an ongoing study at Tufts (hyperlink -- http://csdd.tufts.edu/About/History.asp), the average cost of bringing a drug to market jumped from $231 million in 1991, to $802 million in 2001, to the current estimate of more than $1 billion.  After a product is successfully launched,

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  • Product Risk Management Under ISO 14971:2007 and ICH Q9

    14 June, 2011 John E. Lincoln, J.E. Lincoln and Associates LLC

    Risk management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

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  • 19 Key Elements to Review for Effective Audits

    18 April, 2017 Dr. George L. Harris, DBA, CPM, CPCM, President, Calyptus Group

    Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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  • Please Don't Call Them CAPAs

    18 April, 2017 Denise Robitaille, RAB-QSA Certified Lead Assessor, Author and ASQ Certified

    I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separa

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  • Transfer, Comparability and Co-validation

    12 August, 2011 Melissa J. Smith, Founder and Principal Consultant for MJQuality Solutions, LLC

    This article provides an overview of the elements of transfer with references to supportive documents that contain more detail on the areas of interest regarding transfer and validation.

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  • Good Clinical Practices and the Top Five GCP Violations in a Clinical Study

    18 April, 2017 Michelle Sceppa, Principal at MSceppa Consulting

    Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions (e.g., drugs, biologics, devices, therapy protocols). These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. The regulations that provide a platform for the quality of the data are Good Clinical Practices or GCPs.

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  • Submissions Processes with Templates for Microsoft Word®

    18 April, 2017 Antoinette Azevedo

    As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a

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  • From the Project Manager's Toolbox: Strategies for eCTD Marketing Application Submissions

    Rachel Cooper, Project Manager, Cato Research Ltd.

    Nothing may invoke fear in the heart of new, or even seasoned, regulatory project managers more than the preparation and submission of a marketing application in eCTD format for their company. At first glance, marketing application submissions can appear to be a tedious effort to manage with hundreds of documents and players, and requires orchestrating intricately detailed timelines and intertwined steps. A successful filing is possible but requires beginning with the end in mind by planning f

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