• Your Suppliers’ Risk Is Your Risk

    14 July, 2016 By Carrie Mantey

    In today’s day and age, in which outsourcing can be the norm, and not only major global corporations stretch across the globe, but also potentially mid-market and mom-and-pop suppliers, supply chains are no longer insulated from external or environmental risk events. These risks can range from a natural disaster, such as the Japan earthquake and tsunami, to lax safety policies, in the case of the Bangladesh garment factory collapse, to the regular ebb and flow of business, including when a supplier is acquired or goes out of business. These risks are not new to the supply chain, but as the supply chain grows more complex, so do the risks to supply, especially when visibility is blurred, suppliers are far-flung and there is no backup plan in sight.

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  • What Will Quality Look Like in 20 Years?

    12 July, 2016 Peter J. Holtmann, President and CEO, Exemplar Global

    To look to the future, the quality profession is revisiting its roots. The question is, “Where is the next generation to help the profession look ahead?” Or, as I like to think of it, “What’s the emoticon for quality?”

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  • MasterControl’s Walt Murray Emphasizes “Establishing Design Parameters” at INTERPHEX 2016

    24 June, 2016 Marci Crane, Localization Manager, MasterControl

    INTERPHEX, one of the largest trade shows and combined fairs and exhibitions for the pharmaceutical, biosciences, biotechnology, medical device, and biomedical engineering industries was held last March at the Javits Center in New York, New York. There are 10,000 participants expected every year for INTERPHEX and 2016 was no exception.

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  • Six Steps to Qualifying Suppliers

    16 June, 2016 by Robert Packard, Packard Consulting

    Imagine that you are a QA consultant. Last night you wrote a blog about the three tools needed to qualify suppliers. Today you are auditing a supplier, and have just complimented the purchasing manager on his quality program. During lunch, Kim, the general manager, says, “Michael was just showing me the blog you wrote about how to qualify suppliers. I was confused—your blog seemed to say that we are doing everything wrong, but you just told us that our supplier quality program looks great.”

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  • The Dude Abides! 5 Quotes from “The Big Lebowski” that Apply to Quality

    14 June, 2016 Cindy Fazzi, Staff Writer

    “The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.

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  • Revision is Ongoing for ISO 22000 on Food Safety Management

    9 June, 2016 Sandrine Tranchard, Communication Officer for the International Organization for Standardization

    The consequences of unsafe food can be devastating, both for consumers and businesses worldwide. With many of today’s food products repeatedly travelling across national boundaries, ISO 22000 is more essential than ever to the safety of the global food supply chain. Now the standard is being substantially revised to ensure it stays relevant to modern needs.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • The FDA Just Completed Its Inspection...Now What?

    12 May, 2016 David R. Butcher, Marketing Communications, MasterControl

    Even after an FDA investigator has completed an inspection at your facility, there’s still plenty of work that remains. At the conclusion of an audit, the inspector will hold an exit interview to discuss observations and present significant findings on a Form 483. What do you do next?

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  • Income Tax Myths and Document Control Systems

    5 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’ve been reading Steve Berry’s novel, “The Patriot Threat.” The crux of the book is that the 16th Amendment to the Constitution, the one that requires Americans to pay income tax, may be illegal. The story goes that some of the states may have never ratified the Amendment, and some may have ratified a document that didn’t have the same wording as others. (I won’t spoil the mystery by telling you what transpires.)

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  • Six Signs of Potential FSMA Fakes

    31 March, 2016 Nye Joell Hardy, Food Safety Technical and Regulatory Writer

    Since companies that grow or process fresh produce are now required to follow the Food Safety Modernization Act of 2011, it should be no surprise that there are people out there trying to make a buck off of all that confusion and desperation. Some of these companies are honestly putting their best food forward in trying to meet your needs, but there are others you should worry about, especially if they say any of these six things:

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  • ISO 9001:2015 - A Powerful Addition to Your Professional Tool Kit

    29 March, 2016 Greg Peckford Founder, Quality Career Advancement

    There are over one million organizations in over 170 countries registered to ISO 9001. That alone is a pretty impressive statistic claimed by www.iso.org. But what this stat is missing are the countless other companies worldwide that have adopted the ISO 9001 standard as a blueprint for the development and implementation of their quality management systems without becoming formally certified.

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  • Why We Trek to Trade Shows

    14 March, 2016 Jill Bumgardner, Global Events Manager, MasterControl

    Most people generally support the notion that trade shows are still relevant, but sometimes a little pep talk is in order.

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  • Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

    11 March, 2016 Robyn Barnes, Marketing Communications, MasterControl

    You may be familiar with what a quality management system (QMS) is, but do you know how to use one at a cross-enterprise level?

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  • When Is A CRO Not A CRO? (And why does that make enforcement hard?)

    11 February, 2016 amie Colgin, Colgin Consulting

    Investigator site personnel recorded observations about clinical trial subjects in paper medical charts. Lab work was performed and interpreted at a local lab; X-rays and ECGs were taken and interpreted locally; and results were sent back to the investigator.

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  • One Q & a Lotta A’s about SOPs for Research Sites

    2 February, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    “What are your thoughts about having SOPs for clinical research sites versus having working guidelines in lieu of SOPs?”

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  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

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  • Big Changes for ICH GCP & EU Regulations

    31 December, 2015 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

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  • Using Quality by Design to Improve Manufacturing

    22 December, 2015 Ronald D. Snee, PhD Snee Associates, LLC

    Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV), or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).

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  • How Performance Excellence Helps Broaden the Horizons of Quality

    7 December, 2015 Mickey Garcia, Segment Manager, Medical Devices, MasterControl

    Since W. Edwards Deming’s pioneering work in the 1950s, we have witnessed remarkable progress in the disciplines of both quality and management. Through the years, the best practices of the day have been given fancy names such as total quality management (TQM), Six Sigma and, most recently, Lean everything—just to name a few. With so many hifalutin terms being bandied about, it would be easy to dismiss an emerging term like performance excellence as just another buzzword. But there’s a case to be made for incorporating it more fully into our quality-related vocabulary: to help us, as Dr. Mikel Harry says, look beyond the mere business of quality and focus increasingly on the quality of business.

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  • The Future of Medical Device Registries

    17 November, 2015 David R. Dills, Sr. Consultant, Regulatory & Compliance, Devices: NovusLife

    A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention. Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians. A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition. This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.

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