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    MasterControl – Quality & Compliance Management PodCast – MasterControl

    To stay competitive in a rapidly advancing global market, manufacturers must be able to produce products of the highest possible quality while maintaining compliance with regulatory standards set forth by agencies such as the FDA and ISO. Quality-minded businesses must always be on the lookout for ways to reduce costs, eliminate risks, increase revenue, and accelerate compliance. Each MasterControl podcast address these topics as well as quality issues, industry trends, and compliance matters in an effort to help manufacturers better achieve their quality goals. Quality and compliance issues such as document management, corrective and preventive actions (CAPA), audits, change control, training, supplier management, nonconformance disposition, customer complaints handling, and similar quality topics are regularly discussed by seasoned professionals with strong quality and compliance backgrounds.

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    Latest Episodes:
    Debunking the Myth That Digitzation is Costly and Time Consuming Jun 05, 2021
    Show notes

    Manufacturers have been conditioned to believe the myth that an expensive, complex MES is the path to automating the shop floor. But new technologies today are providing smarter, faster, and less expensive alternatives – where production records, training documents, SOPs, and more are quickly and cost-effectively digitized under one platform. And the simplicity of these systems extends to user adoption and configurability that easily maps to your existing processes.

    This webinar will explore alternative technology for paperless manufacturing that integrates with existing ERP and QMS investments for a fully connected manufacturing experience. It will showcase manufacturers who have implemented MasterControl Manufacturing Excellence™ and their simplified path to digital adoption, plus metrics achieved by improving data integrity and right-first-time (RFT) metrics, reducing deviations, shortening review time, and accelerating product release.

    For manufacturers that have been slow to adopt digital technology for fear that solutions are too complex or costly, this webinar will present a smarter, more cost-effective path to digital adoption and manufacturing excellence.


    Uniting Quality and Manufacturing With Digitization by MasterControl May 17, 2021
    Show notes

    Innovation and technology in the life sciences made it possible to develop the COVID-19 vaccine in record time. With inspiring advances like that, the question becomes: “How can we still be using paper?” The pandemic truly highlighted the constraints of paper and siloed systems, and maybe that’s a good thing, because it has also propelled companies to think seriously about digitization.

    Here’s what you can expect with connected systems: • Visibility between quality and manufacturing functions. • Say goodbye to deviations, nonconformances, and scrap. • Production record review in record time.

    The good news: integrating digital systems is not as hard as you think, just start with preparation. When firms plan their efforts, they can start small and scale quickly to see improvements.

    Key takeaways for this presentation include: • How digitization gives you a competitive advantage and increases resiliency. • Benefits of integrating quality and production. • The ROI for integrating quality and production and how to calculate that. • How to identify the right system for your organization.

    Presenters Brian Beckstead, Product Manager, MasterControl Jamie Nowacek, Product Manager, MasterControl


    How Digitization Facilitates Safe and Connected Operations During and Beyond Post Covid-19 Manufacturing Apr 23, 2021
    Show notes

    COVID-19 exposed weaknesses in manufacturing, but those weaknesses were impacting shop floors long before the pandemic. Thankfully, the industry march towards digitization is offering new levels of flexibility. And manufacturers will benefit both during COVID-19 and beyond. Join us as we explore how to:

    • Improve manufacturing time by ditching paper-based processes.

    • Implement fully configurable digital systems.

    • Increase visibility and communication on the shop floor.

    • Make it easier for workers to operate remotely.

    • Maximize productivity, eliminate data input errors, and streamline the compliance process. Don’t miss this chance to explore the new solutions that are essential in maintaining your competitive edge.

    Presenters: Brian Curran, SVP of Strategic Growth, MasterControl and Katie Farley, Product Manager, MasterControl

    Link to Webinar Replay.

    https://www.mastercontrol.com/learning-center/all-videos/how-digitization-facilitates-safe-and-connected-operations-during-and-beyond-post-covid-19-mfg


    Navigating Constant Change With Flexible Quality Systems Feb 05, 2021
    Show notes

    Since the COVID-19 pandemic started over a year ago, businesses have learned that constant change is the new normal. There will always be outside forces that companies need to adapt to, many of which are unforeseen, and there’s a continual need for resilience. One of the things that MasterControl customers have noticed is how going digital and using our solutions helps them when these issues arise. They can communicate more effectively, keep their operations going, and maintain quality with minimal interruption.

    We’ve already moved our customers from paper to digital — now we’re focused on data intelligence. Data intelligence is all about using artificial intelligence (AI) and machine learning (ML) to make data-driven decisions. Or, in some cases, simply enabling the applications to make those decisions without human involvement. This level of connectivity brings quality into every part of your organization, giving you a true culture of quality.

    Key takeaways from this session include:

    • How common quality pains are solved by digitizing.
    • How a connected platform allows improved agility/resilience.
    • The benefits of connecting quality data and using it to drive decision-making.
    • How a culture of quality driven by connected data and metrics can help your business thrive.

    Manufacturing Technology: Features and Functionality for Changing Environments Feb 05, 2021
    Show notes

    COVID-19 has exposed issues within the manufacturing industry, which may never be the same. The global pandemic illustrates why it is critical for manufacturers to be adaptable. Forward-thinking companies need to adopt the right technology now to ensure they can adapt to the current environment and prepare for the future.


    The Rise of Intelligent Quality: Shifting to Flexible and Dynamic Processes Feb 05, 2021
    Show notes

    The traditional approach to quality in the life sciences has mainly been focused on control and standardization. As the industry continues to evolve, companies are finding it necessary to incorporate flexibility and improved collaboration into their quality management methodologies. These shifts are creating exciting opportunities to leverage emerging technologies like artificial intelligence, machine learning and natural language processing for data collection, analysis and connectivity.


    The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation Feb 05, 2021
    Show notes

    Outsourcing isn’t a trend in the life sciences – it’s the new way of doing business. MasterControl Executive Vice President of Product Matt Lowe discusses the challenges posed by modern business ecosystems and the criticality of extensible and flexible quality management systems. Lowe will examine the many ways technology platforms can help companies expand quality’s footprint while also enhancing their control over operations and data.

    He is joined by Matthew Seitz-Paquette of Fagron who will examine some real-world applications and show the power of QMS extensibility by explaining how the personalized medicine and compound pharmaceutical company has leveraged advanced digital tools to align quality processes between multiple global sites and streamline its training processes.

    Lowe and Seitz-Paquette will share examples of the benefits that can be achieved by effectively connecting quality data and processes with robust platforms.


    Episode 10: Future Proofing – Digital Production Records, QMS and Validation Feb 04, 2021
    Show notes

    Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 10 of this 10-part series, SVP of Strategic Growth Brian Curran and Principal Product Management Director Terrance Holbrook talk about how to stay flexible for future changes by digitizing.

    Key takeaways include: • The adaptability of a digital production records system. • What to look for in a quality management system (QMS). • The benefits of risk-based validation.


    Episode 9: Future Proofing – Continuing Production Beyond Exemption Feb 04, 2021
    Show notes

    Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 9 of this 10-part series, Senior Director Public Relations and Content Jennifer Hurst and Principal Product Management Director Terrance Holbrook talk about how digitizing will help companies prepare for the aftermath of the pandemic.

    Key takeaways include: • How the pandemic has shaped exemptions. • What companies can do once the pandemic has resolved. • How a culture of quality prepares your company for the future.


    Episode 8: Documentation – Quality Event Management and Audit Feb 04, 2021
    Show notes

    Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 8 of this 10-part series, Product Manager Kim Jackson and Principal Product Management Director Terrance Holbrook talk about digitizing quality event management and how it can improve an organization.

    Key takeaways include: • Importance of process improvement in QEM. • Problems solved by digitizing QEM. • Factors to keep in mind while digitizing.


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