GxP Lifeline

 

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

    January 21, 2021 By David Jensen, Staff Writer, MasterControl

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

    January 20, 2021 By Andrea Artman, Founder, SpectRA Compliance, LLC

    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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  • The Future of Quality Is Artificial Intelligence

    January 19, 2021 By Sarah Beale

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

    January 14, 2021 By David Butcher, Staff Writer

    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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  • Future Trends and Opportunities in Quality Assurance

    January 13, 2021 By David Jensen, Staff Writer, MasterControl

    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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  • How a Force Multiplier Elevates Your Organization’s Success

    January 12, 2021 By David Jensen, Staff Writer, MasterControl

    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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  • 2021 is the Year of Supply Chain Optimization

    January 7, 2021 by James Jardine, Staff Writer

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

    January 5, 2021 By David Butcher, Staff Writer

    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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  • 5 Ways 2020 Changed the Regulated Medical Industry

    January 4, 2021 By Regina Fullin, VP of RA/QA Consulting

    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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  • A Risk-Based Approach to Validation

    December 30, 2020 By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners

    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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  • Effective Nonconformance Management Key to FDA and ISO Compliance

    December 22, 2020 By Jason Clegg, Marketing Strategy Director, MasterControl

    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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  • Five Best Practices for Ensuring Supplier Quality

    December 21, 2020 By David Jensen, Staff Writer, MasterControl

    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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  • Integration Brings These 3 Advantages

    December 17, 2020 By Dale Thompson, Staff Writer, MasterControl

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

    December 16, 2020 By Kathleen McHugh, Systems Lead Engineer, MPR Associates, Inc.

    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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  • Three Quality Management Trends to Watch in 2021

    December 15, 2020 By Richard Goeb, Quality Team Member, Cannon Quality Group

    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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  • 5 Advantages of Connected Manufacturing

    December 14, 2020 By Dale Thompson, Staff Writer, MasterControl

    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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  • Selling the C-Suite on Connected Quality Data

    December 10, 2020 By Sarah Beale

    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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  • A Q&A About the North Pole’s Manufacturing

    December 9, 2020 By Sarah Beale

    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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  • Brexit and the Impact on the IVD and MD Industries

    December 8, 2020 By Dr. Dirk Stynen, Owner, President and Principal Consultant, Qarad

    On January 1, 2021 the United Kington will leave the European Union. The implications of this move have a significant impact on manufacturers.

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  • Quality Assurance, Quality Control and Quality Management: Clarifying Confusion

    December 4, 2020 By James Jardine, Staff Writer

    With so many similar sounding terms related to quality in life sciences manufacturing, it’s easy to get confused about their definitions and intersections. Learn the purposes of quality assurance, quality control and quality management, their overlap and the differences between each critical function.

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