• Cleanroom Compliance: How to Address Common Challenges in Document Control

    5 May, 2016 Dave Hunter, Product Management Director, MasterControl

    A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).

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  • Top 10 Medical Device Inventions Critical to Parenting

    3 May, 2016 Robyn Barnes, Marketing Communications, MasterControl

    I’m a medical device article junkie and I love all those “Top 10” lists that everyone publishes. Recently I saw one entitled “Top 50 Medical Device Inventors of All Time.” Nice article but it had a few flaws. First, most of the inventors were men. Who doesn’t know that necessity is the mother of invention?

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  • Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products

    28 April, 2016 Jeffrey K. Shapiro & Charlene Cho Hyman; Phelps & McNamara, P.C.

    In the emerging world of regenerative medicine, there is a stark dichotomy in the level of regulation applied to products derived from human cells and tissues, or what FDA calls “human cells, tissue or cellular and tissue‑based products” (HCT/Ps).

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  • Don’t Trip over These 9 Document Control Pitfalls

    26 April, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • 4 Downton Abbey Characters Who’d Make Great Quality Professionals (and 4 Who’d Be Bloody Awful)

    21 April, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Are you experiencing Downton withdrawal now that the award-winning PBS costume drama is officially over? You’re not alone. Monday morning water cooler banter hasn’t been the same since our friends in the Great House threw the dust shields over the furniture and bid us farewell. If you’re missing your favorite Downton characters, don’t fret. There is probably a Mr. Carson or Lady Mary sitting in the cubicle next to you. After all, several members of the Crawley household, upstairs and down, possess the skills and personality traits needed for a successful career in quality management—others clearly don’t. Warning: Spoilers ahead!

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  • 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.

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  • The Importance of Applying Risk-based Design Control to Process Validation

    18 April, 2016 Lisa Weeks, MasterControl Communications

    In order to have a successful submission for approval of drugs, medical device, biotechnology, supplements, combination product and IVD an organization must have a prolific and structured design process. According to regulators, this process must now include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.

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  • CFDA Medical Device Software Regulation Undergoes Major Revision

    14 April, 2016 Beth Pedersen, Marketing Communications, MasterControl

    With so many international regulatory bodies governing different countries and industries, it can be difficult for manufacturers to stay abreast of all of the changing regulatory environments and requirements across the globe. On August 5, 2015, China Food and Drug Administration (CFDA) released its “Principle of technical review of medical device software” (2015 Order No. 50). The principle, which is only available in Chinese, signals a major change for documentation requirements for stand-alone software or software components developed by medical device manufacturers or their development partners.

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  • Med Device: How to Address the Documentation Burden of Design Control

    12 April, 2016 Matthew M. Lowe, Executive Vice President, MasterControl

    Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

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  • Can’t-Miss Tips for Exposing Risk during Medical Device Development

    7 April, 2016 Lisa Weeks, MasterControl Communications

    Do you confuse risk analysis with risk assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.

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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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  • Compliance, Innovation and GMPs at the 32nd SQA Annual Meeting & Quality College

    4 April, 2016 Robyn Barnes, Marketing Communications, MasterControl

    If you’re not cultivating a culture of quality at your workplace, what are you doing to improve compliance, innovation and good manufacturing practices (GMPs)?

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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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  • Quality Management has Moved On!

    24 March, 2016 Andrew Foy Owner, Foy Certification Ltd.

    Quality assurance was originally conceived to document a set of procedures aimed at ensuring that quality standards and processes were adhered to by a business; but has now moved beyond the tick box concept and can play an integral part in improving business performance.

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  • Stop Asking Why

    22 March, 2016 Harish Jose, Senior Quality Engineer, ASQ CRE, ASQ CQE, ASQ CSSBB, ASQ CBA

    My friend was doing data analysis of ERP transactions, and he noticed that the material handler was creating transactions in two different programs for dock-to-stock components. This process created double entries and did not seem to add value. He asked the question “why” and the material handler reported that she was doing it because it was the way she was trained, and because it was the way they had always done it.

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  • The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

    17 March, 2016 Dr. Candida Fratazzi, M.D., Founder/CEOBBCR Consulting, (Boston Biotech Clinical Research)

    The average cost of developing a new drug is notoriously high. In a study conducted through the Tufts Center for the Study of Drug Development in 2014, Dr. Henry G. Grabowski and Dr. Ronald W. Hansen concluded, “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is 2,558 billion.” The story does not end here. For the past 20 years, the cost of new drug development has risen at a rate that was 7.4% higher than inflation, and clinical trials bear responsibility for most of that increase. However, the increasing cost of biomedical research is not reflected in an increase in the success rate of clinical development. Instead, it presents a major hindrance to innovation in the biotech industry, while the public must bear the brunt of the problems, absorbing the steep rise in the prices of drugs and medical devices. In order to boost the efficiency of the biotechnology industry, remove the burden of expensive drugs, and create life science products in line with the future of healthcare, we should be asking how best to modify the development process to make it cost-effective.

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  • Study Sites: Too Many Vendors, Too Little Time

    15 March, 2016 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants, Inc.

    Sound familiar? Sprinkle in some colorful adjectives and it probably does -- these problems are common enough at clinical research sites. Equipment and systems have become increasingly technical and specialized, and study site staff has had to contend with more technology than ever before. And because of the proliferation of niche vendors who provide the new tech, sites have had to deal with more vendors than ever before, too.

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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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