GxP Lifeline

 

Showing items tagged as Supplier

  • 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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  • 5 Areas of Focus When Conducting a Supplier Audit

    October 16, 2020 By David Butcher, Staff Writer

    For manufacturers, supplier auditing is essential to gaining visibility into whether a supplier’s products and processes are adhering to a defined quality standard. According to Terrance Holbrook, MasterControl’s director of product, there are five often-overlooked actions that manufacturers can take to improve how they conduct supplier audits.

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  • Digital Tools to Streamline Supplier Management Processes

    July 24, 2020 By David Butcher Staff Writer, MasterControl

    The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.

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  • SPC vs SQC: The Strategic Difference

    July 17, 2020 By Jason Orloff, Statistical & Engineering Consultant, Pharmstat

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • How to Increase the Value of Your Supplier Audits

    April 9, 2020 by Angelo Scangas, President and CEO, Quality Support Group (QSG)

    A manufacturer’s ability to maintain high-quality products and regulatory compliance depends largely on its suppliers’ own quality-related activities. Leveraged correctly, supplier audits can be an important tool that gives manufacturers greater visibility into these activities, according to Quality Support Group CEO Angelo Scangas.

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  • How Coronavirus, Brexit and Hurricanes Are Impacting the Global Supply Chain

    March 17, 2020 by Gina Guido-Redden, Co-Founder and COO, Coda Corp USA

    Coronavirus is the newest in a string of natural and man-made disasters and events disrupting the global supply chain. Governments and the private sector need to take a collaborative risk-management approach to planning measures to confront pandemics and other events that threaten the stability of global supply chains and our ability to meet ensuing demand.

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  • How Healthy Is Your Supply Chain?

    March 10, 2020 by Sarah Beale, Staff Writer, MasterControl

    Life sciences supply chains are unique. Pharmaceutical and medical device are even more so. Finding out industry standards and how your supply chain can improve are important questions that should be answered by the experts. Gartner recently produced “Supply Chain Benchmarking Data Reveals Differences Between Pharmaceutical and Medical Device Manufacturers” to provide those insights.

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  • Disruptive Outsourcing Means Life Sciences Are Relying on CMOs More Than Ever

    January 28, 2020 by Mike Rigert, Staff Writer, MasterControl

    Life sciences manufacturers’ reliance on outsourcing is on an upward trajectory. However, recent disruptions to how and why companies turn to contract manufacturing organizations (CMOs) and related contract services are changing the playing field. To maintain quality and control of products in this more dynamic outsourcing ecosystem, companies should seek greater collaboration.

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  • 5 Key Questions About Quality Agreements

    June 11, 2019 by Arvilla Trag, RAC, Consultant, BioProcess Technology

    Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.

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  • How Blockchain May Affect Manufacturing

    March 26, 2019 by David Butcher, Staff Writer, MasterControl

    Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.

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  • Supply Chains Are High Risk For Hardware Hacking

    March 14, 2019 by David Jensen, Staff Writer, MasterControl

    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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  • 5 Ways to Digitally Transform Your Supply Chain

    January 29, 2019 by David Butcher, Staff Writer, MasterControl

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

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  • Call and Response: RFPs and Vendor Proposals

    January 10, 2019 by Ray Sison, VP of Pharmaceutical Outsourcing and Tech Transfer, xCell Strategic Consulting

    In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.

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  • A Risk-Based Approach to Auditing and Qualifying Suppliers and Vendors

    December 18, 2018 by Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company

    For a manufacturer, qualifying vendors and suppliers can be challenging due to varying philosophies and expectations. To avoid ambiguity and uncertainty, manufacturers should have SOPs and policies for interacting with vendors and suppliers. Audits and quality assurance assessments will go smoother with open and clear channels of communication between all parties that will result in improved compliance.

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

    August 14, 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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  • Using a QMS to Qualify Your Suppliers

    August 2, 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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  • Best Practices for Supplier Evaluation and Rationalization

    July 26, 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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  • Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    July 3, 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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  • What Biotech Startups Need to Do to Slay the Competition

    June 21, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • Medtech Startups: How to Survive Cutthroat Competition

    June 19, 2018 by Matthew M. Lowe, Executive Vice President, MasterControl

    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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