GxP Lifeline

 

  • Avoiding the Top 5 Violations of 21 CFR Part 111

    23 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    All dietary supplement companies must comply with the CGMPs outlined in 21 CFR Part 111. However, doing this and recording it is easier said than done. The top 5 violations recorded by the FDA show which areas need the most improvement and how automated systems can help

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  • Keeping Up With Regulatory Changes for Medical Devices

    4 September, 2018 by Michelle Lott, Principal and Founder, Lean RAQA

    Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.

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  • Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

    15 August, 2018 by Carla Frances Reed, President, New Creed

    A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

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  • Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 1

    14 August, 2018 by Carla Frances Reed, President, New Creed

    A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

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  • Pregnancy and Medical Device Submission Management: Can the Pain Be Reduced?

    29 August, 2018 by Marci Crane, Staff Writer, MasterControl

    At first glance, the processes of human pregnancy and medical device submission management are as “non-workable” as peanut butter and cinnamon or popcorn and ketchup. However, it’s surprising how many pains these two forms of labor have in common.

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  • Artificial Intelligence: Is It on the Cusp of Revolutionizing Pharmaceuticals?

    21 August, 2018 by Mike Rigert, Staff Writer, MasterControl

    One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

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  • 7 Ways That Medical Device Design Control Helps the Design Engineer

    28 August, 2018 by Edwin Waldbusser, Medical Device Regulatory Consultant, Medical Device SOP Advisors

    The design and development of a medical device can be fraught with surprises and challenges for the design engineer. Learn how to avoid these hiccups by implementing solid design controls that can help the process run smoother, and better yet, see the device ready on-time and on-budget.

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  • Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    9 August, 2018 by David Jensen, Staff Writer, MasterControl

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • Why the Cloud Is the Key to Easing Your Validation Burden

    16 August, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    If your organization spends several weeks or months performing software validation, you’re not alone. Most regulated companies do. But, Erin Wright, MasterControl’s validation product manager, said validation doesn’t have to be as burdensome anymore. The powerful cloud technology, combined with a risk-based approach, is the key to a faster and better validation process.

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  • Using a QMS to Qualify Your Suppliers

    2 August, 2018 by Sarah Beale, Staff Writer, MasterControl

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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  • How to Gain Entry to Latin America’s Medtech Market

    7 August, 2018 by Julio G. Martinez-Clark, CEO, LATAM Market Access

    Don’t get bit by piranhas and crocodiles when entering Latin America’s lucrative $31 billion medical device manufacturing industry. Learn from a pro the tips, strategies and trends you’ll need to be successful in the golden medtech market in North and South America.

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  • Best Practices for Supplier Evaluation and Rationalization

    26 July, 2018 by Carla Frances Reed, President, New Creed

    Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

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  • The #1 Gap in Manufacturing Software Today

    18 July, 2018 by Beth Pedersen, Staff Writer, MasterControl

    It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

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  • Regulatory Manager Tip: Making Your Voice Heard at the FDA

    17 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    As a life science manufacturer, how can I minimize risk and hiccups before seeking U.S. Food and Drug Administration approval for my product? Learn how to make your voice heard at the FDA in this month’s Regulatory Manager Tip.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • Using the Newly-Approved Dietary Fibers in Supplements

    19 July, 2018 by Sarah Beale, Staff Writer, MasterControl

    Many consumers don't get enough fiber, leading to health problems that are especially prevalent as people get older. Fiber supplements can help fill the gap, and now the FDA has expanded its definition of dietary fiber to include eight more sources.

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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    3 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 2

    12 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers. Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

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  • How AI Tools Will Transform Quality Management in the Life Sciences, Part 1

    10 July, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

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