• 2021-bl-global-regulatory-strategy-plan_132x132

    How to Create an Effective Global Regulatory Strategy and Plan

    An integral part of remaining compliant is having and maintaining a strong global regulatory strategy. Before diving in and creating a strategy, understand what to include so it’s effective. A global regulatory strategy ultimately saves your organization time and money while making it possible to get product to market more quickly.

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  • 2021-bl-spectra-terms-explained-2_132x132

    Can I get a Translation Please? Tips to Ensuring Productive Communications with Regulatory Authorities, Part Two

    Understand simple strategies for communicating with your review team to ensure you’re speaking a language that your regulatory authority understands, and more importantly, a language that can get your product to market.

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  • 2020-bl-asca-final-guidance_132x132

    The FDA Publishes Three-Part Final Guidance on ASCA Pilot Program

    In Sept. 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies and testing laboratories. The FDA released its final guidance in Sept. 2020. This article highlights key aspects of the updated guidance.

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  • 2021-bl-spectra-terms-explained_132x132

    Can I get a Translation Please? Tips to Ensuring Productive Communications with Regulatory Authorities, Part One

    Miscommunications can stall regulatory reviews and approvals. Avoid the frustration. In the first half of this two-part series, an expert shares her tips on how to prepare your regulatory submission. The trick is to “translate” your scientific and engineering outcomes so they can be easily understood by regulatory authorities.

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  • 2020-bl-optimization-opportunities-data-ai_132x132

    The Future of Quality Is Artificial Intelligence

    Artificial intelligence (AI) isn’t just a cool tech trend. At the rate it’s going, it’s shaping the future of quality in the life sciences. Which is why we’ve designed a new data analytics solution that gives users complete control over their data and uses AI to drive decision-making.

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  • 2021-bl-fda-called_132x132

    The FDA Just Called! Are You Ready for an Inspection?

    If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic or would you go on about your day, business as usual? FDA audits can be stressful, and failing one can have significant consequences. With proper preparation, however, the call to schedule an FDA inspection doesn’t have to be so unnerving.

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  • 2020-bl-future-trends-opportunities_132x132

    Future Trends and Opportunities in Quality Assurance

    At a previous PDA/FDA Joint Regulatory Conference in Washington, D.C, Donna Gulbinski, quality and regulatory affairs expert, provided useful information about the future of quality management. She identified some key strategies for how your organization can identify and understand quality assurance trends and develop initiatives for long-term success.

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  • 2020-bl-alan-rencher-highlights_132x132

    How a Force Multiplier Elevates Your Organization’s Success

    At MasterControl’s Virtual Masters Summit 2020, vice president of engineering Alan Rencher provided valuable insight about force multiplication and how it gives companies the ability to seamlessly integrate business units, excel in all aspects of operations and sustain a competitive advantage.

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  • 2020-bl-supply-chain-optimization_132x132

    2021 is the Year of Supply Chain Optimization

    In the wake of a global pandemic, supply chain disruptions that were once inconveniences have become existential threats to many life sciences companies. Learn the steps your organization can take to build a more resilient supplier ecosystem.

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  • 2020-summit-keynotes-overview_132x132

    Virtual Masters Summit 2020: Digital Transformation and Data in a Time of Uncertainty

    Every organization is dealing with a deluge of data and the challenges of uncertainty. Companies are drowning in data but starving for insights in a time of rapid change, both domestically and globally. What’s needed is the ability to easily access, analyze and apply data in real-time to current challenges, while using the information to better plan for and shape the future. At Virtual Masters Summit 2020, two thought leaders highlighted ways that emerging technology and data can help life sciences organizations move forward during uncertain times.

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  • 2020-bl-5-ways-2020-changed_132x132

    5 Ways 2020 Changed the Regulated Medical Industry

    With 2020 behind us, let’s take stock of what happened during the year and how the face of regulated medical industry has changed. Heading into 2021, be ready for remote options, deferred enforcement of regulations and more.

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  • 2020-bl-risk-based-approach-validation_132x132

    A Risk-Based Approach to Validation

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

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  • 2020-bl-nonconformance-management_132x132

    Effective Nonconformance Management Key to FDA and ISO Compliance

    It’s impossible to avoid occasional nonconforming products and materials. But what’s most important for manufacturers of regulated products is how nonconformances are managed. Learn how to handle nonconformance challenges, avoid warning letters and maintain alignment with FDA and ISO requirements.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • 2020-bl-integrations_132x132

    Integration Brings These 3 Advantages

    Integrate disparate systems and get the most out of your investment in technology designed to streamline manufacturing operations. This will make it possible to improve efficiency, eliminate mistakes and scale quickly.

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  • 2020-bl-mpr-risk-management_132x132

    ISO 14971:2019 Risk Management: Keeping up with current expectations

    With the update to internationally recognized standard ISO 14971: Medical devices — Application of risk management to medical devices late in 2019, many manufacturers have taken a hard look at strengthening their post-production procedures over the past year to make improvements to how risk is managed throughout the entire product lifecycle.

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  • 2020-bl-cqg-quality-mgmt-trends_132x132

    Three Quality Management Trends to Watch in 2021

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • 2020-bl-brian-curran-10-talk_132x132

    5 Advantages of Connected Manufacturing

    Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.

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  • 2020-bl-why-c-suite-interested_132x132

    Selling the C-Suite on Connected Quality Data

    All year we’ve been addressing connected quality data. Since we’re talking about connecting data across the organization, it makes sense that there would be advantages across the organization. Getting executive buy-in requires showing your C-suite how they’ll benefit from a digital transformation.

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  • 2020-bl-q-and-a-santa_132x132

    A Q&A About the North Pole’s Manufacturing

    We recently sat down with North Pole CEO Kris Kringle to chat about how he took his operation from paper to digital. Turns out making presents for children all over the world requires a cutting-edge manufacturing solution.

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