• 2021-bl-six-corporate-oversights_132x132

    The Rise of Risk: How To Meet Pharma Regulators’ Expectations

    Regulators are intensifying focus on risk-based compliance approaches and pharma companies must adapt to the shift. Discover why process digitization provides the surest route to compliant risk management and learn how to prepare for the increasingly risk-based future of regulation.

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  • 2020-bl-matt-brawner-qa_132x132

    Risk Management: A Primer for Lean Quality Assurance

    Be proactive about managing risk. If you aren’t, you will find yourself managing a crisis instead. Learn more about the benefits of risk management and how it’s done.

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  • 2021-bl-ipm-compliance-crisis_132x132

    How to Avoid—but Prepare for—Compliance Crises

    If you prepare for and manage compliance crises with disciplined leadership and formal processes, you can minimize disruption and damage. In fact, your processes, communication, and adaptability can get stronger from the experience.

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  • 2021-bl-embed-risk-based-thinking_132x132

    Embedding Risk-Based Thinking Into Quality Efforts

    Many of the challenges inherent in developing regulated products fall into the realm of risk that manufacturers need to examine and mitigate prior to going to market. Risk management guidelines are spelled out in international regulations and standards, but true risk management goes deeper and is applied throughout the product’s life cycle.

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  • 2021-bl-measuring-risk-management_132x132

    Measuring Risk Management Outcomes

    The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.

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  • 2020-bl-brandwood_132x132

    Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019

    This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.

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  • mind-the-gap_132x132_Thumbnail

    Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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  • 2019-bl-thumb-hacking-manufacturing-supply-chain

    Supply Chains Are High Risk For Hardware Hacking

    The discovery of a mysterious microchip in servers used in U.S. government offices further blurred the line between fiction and reality. While network and software hacking dominates the cybersecurity spotlight, hardware often goes unnoticed and unprotected. Hence, companies are highly encouraged to give some much-needed attention to supply chain security.

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  • 2019-bl-thumb-med-device-trends-2

    2019 Med Device Trends to Watch For: Human Factors Engineering

    To err is human, but if medical device manufacturers can mitigate hazards associated with user errors, so much the better. The U.S. Food and Drug Administration (FDA) requires human factors engineering (HFE) in device development precisely for this reason. Expect HFE to be more important than ever, according to industry experts

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  • 2019-bl-thumb-manufacturing-recall-blunders

    Recall Blunders: How to Avoid Them and How to Recover

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

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  • warehouse-logististics-icons-132

    Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

    Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.

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  • 2021-bl-qarad-eifu_132x132

    Risk Management and the Human Species

    Science has shown that human beings are not immune from making irrational choices when it comes to risk management, even in the life sciences. This can have significant effect on manufacturing processes, and ultimately, patients. Learn how to avoid falling into this trap.

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  • 2018-bl-thumb-fmea-without-tears

    FMEA Without Tears: A Prescription to Reduce Pain and Confusion

    Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

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

    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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  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    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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  • 2018-bl-thumb-top-5-med-device-industry-trends-atypical tech-2

    Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

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  • 2020-bl-vaccine_132x132

    Medtech Startups: How to Survive Cutthroat Competition

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

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  • 2018-bl-thumb-fraud-control-plans

    Why Fraud Control Plans Are Completely Unnecessary

    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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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    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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  • 2018-bl-thumb-compliant-analysis

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

    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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