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GxP Lifeline
  • 2021-bl-effective-failure-investigation_132x132

    Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

    The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.

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  • 2021-bl-measuring-risk-management_132x132

    How to Measure 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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  • 2021-bl-wellington-foods_132x132

    Quality Is the Key Ingredient to Successful Manufacturing

    The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.

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  • 2021-bl-ai-emerging-tech_132x132

    3 Practical Ways to Prepare for Pharma’s AI-Driven Future

    Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.

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  • 2021-bl-investigational-device_132x132

    FDA’s IDE: Data-Centric Approach to Med Device Innovation

    An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.

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  • 2021-bl-data-driven-quality-model_132x132

    Adopting a Data-Driven Quality Model: Essential for Quality and Compliance

    Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. This article explains how companies are emerging as leaders in their industries by implementing a data-driven approach to quality management.

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  • 2021-bl-understanding-acronyms_132x132

    Making Sense of LIMS, QMS, GMP and Other ERP Acronyms for Life Sciences

    Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.

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  • 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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  • 2021-bl-spectra-terms-explained_132x132

    Can I get a Translation Please? 3 Tips to Ensure Productive Regulatory Communication, 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-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-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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