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Showing items tagged as Risk Management

  • Why Fraud Control Plans Are Completely Unnecessary

    3 May, 2018 by Rod Farrar, Director, Paladin Risk Management Services

    With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Complaint Analysis: Don’t Forget the Work You’ve Already Done

    5 April, 2018 by Jake Walton, Corporate Operations Quality Manager, MasterControl

    This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.

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  • HIPAA Compliance and Data Security Demand Equal Attention

    2 November, 2017 by David Jensen, Staff Writer, MasterControl

    The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules. However, rapidly advancing technology and security threats are pointing a spotlight on the Privacy and Security rules that apply to electronic protected health information (ePHI).

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  • Risk Mitigation in Clinical Research: It Starts with Study Startup

    31 October, 2017 by Craig Morgan, Marketing and Brand Development, goBalto

    For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.

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  • Supply Chain Risk Management: An Ever-Changing Mosaic

    19 September, 2017 Geary W. Sikich, Principal, Logical Management Systems Corp.

    We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

    11 April, 2017 David Jensen, Staff Writer, MasterControl

    I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen, Staff Writer, MasterControl

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    2 February, 2017 by Lisa Weeks, Staff Writer, MasterControl

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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  • 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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  • Aligning ISO 13485:2016 With Additional Standards and Regulations

    13 July, 2016 Marci Crane, Localization Manager, MasterControl

    MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.

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  • MasterControl's Murray Defines Risk---and What It Isn't

    29 June, 2016 Marci Crane, Localization Manager, MasterControl

    For medical manufacturing professionals, the MD&M conferences and exhibits are some of the most valuable professional networking tools available. At MD&M East, medical manufacturing professionals, from the eastern United States and from areas spread across the world, meet together with regulatory, quality, compliance, and manufacturing experts to glean and share knowledge. Tracks covered over the course of the most recent conference, held June 13.-15, 2016, focused on “Market Value and Consumer Health, New Technologies, Big Data, and Mobile Product Risk.”

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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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  • 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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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • The Past, Present and Future of CAPA

    23 February, 2016 James Jardine, Marketing Communications Specialist, MasterControl

    Every day, companies in regulatory environments are amplifying their efforts to avoid the seemingly inescapable consequence of an egregiously oversaturated corrective and preventive action program, or, as it’s commonly come to be known, “Death by CAPA”. A recent MedTech Intelligence article by CAPA guru Ken Peterson speaks to the evolution of CAPA, discusses the refinement of effective CAPA programs and hints at what is on the CAPA horizon in the future.

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  • New Developments in IEC 60601 Amendment 1 & Risk Management: Part I

    19 January, 2016 Mark Leimbeck, Program Manager, UL EduNeering

    When the 3rd Edition of IEC 60601 was published, two significant changes from the 2nd Edition were introduced: first, an expansion in the scope of the Standard from Basic Safety (only) to include Essential Performance; and second, introduction of a requirement for assessment of the Risk Management process applied by manufacturers in developing their medical devices.

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  • The ISO 9001: 2015 Change Train is Gathering Steam

    6 May, 2015 Robyn Barnes, Marketing Communications, MasterControl

    ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

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  • Creating a High Performance and Low Risk Work Culture

    5 May, 2015 David Patrishkoff, President, E3- Extreme Enterprise Efficiency

    Most of us have heard the phrase: "Culture eats strategy for breakfast." It could also be restated as "Your actions speak louder than your words." This means that management can dream up any strategy they want to but their behaviors and actions are what creates the culture of an organization, not their strategy. Culture drives the efficiency of an organization's processes. The culture drives the success or failure of an organization. The culture is the product of leadership decisions or the lack

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