The BioPharma Quality Systems Podcast

NoviSystems
  • 5.0 (1)
  • TECHNOLOGY

Explore how to enhance BioPharma manufacturing quality with Fusion Analytics.

  1. 12/06/2022

    Ep19 - Science-backed FDA Investigations

    Mike Kowolenko, Juan Torres, and John Ward discuss how FDA investigations can benefit all parties in the industry if they are backed by science.

    21 min

  2. 11/29/2022

    Ep18 - Validation in Today's Data-Driven Environment - Part 2

    Mike Kowolenko, Juan Torres, and John Ward continue their discussion from Episode 17 on validation in today's data-driven manufacturing environment.

    23 min

  3. 11/22/2022

    Ep17 - Validation in Today's Data-Driven Environment

    In this episode Mike Kowolenko, Juan Torres, and John Ward discuss the relevance of older validation methods in today's biopharma manufacturing data-driven process environment.

    25 min

  4. 11/15/2022

    Ep16 - FDA's QMM Program

    In this episode, NoviSystems CEO, Mike Kowolenko, and Chief Quality Advisor, Juan Torres, explore the FDA's Quality Management Maturity program, what it means for biopharma manufacturing operations, and its objective to reduce drug shortages.

    24 min

  5. 11/08/2022

    Ep15 - Origins of NoviSystems

    In this episode, Dr Mike Kowolenko discusses the NoviSystems origin story and the requirements for our Fusion Analytics for Quality Systems products.

    11 min

  6. 11/02/2022

    Ep14 - Working with Data Scientists

    Mike Kowolenko discusses the role of data scientists, how they can contribute to a biopharma manufacturing organization and how to utilize them to achieve both their effectiveness and their retention. NoviSystems builds system to reduce the time and costs required to perform the batch release process. Contact us at info@novi.systems to learn more.

    15 min

  7. 10/25/2022

    Ep13 - Digital Transformation for Drug Product Release

    Dr. Mike Kowolenko discusses the benefits of digital transformation and data-driven decision-making in the drug release process - including the opportunity to reduce the time and effort required.

    20 min

  8. 10/18/2022

    Ep12 - Change is a Requirement for Quality

    In this episode Mike Kowolenko and Juan Torres explore the external forces that make change a requirement in quality systems.

    22 min
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Explore how to enhance BioPharma manufacturing quality with Fusion Analytics.

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