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The BioPharma Quality Systems Podcast

by NoviSystems

Technology

Explore how to enhance BioPharma manufacturing quality with Fusion Analytics.

From the show's RSS feed, refreshed Jun 28, 2026. Source feed.

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Episodes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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...

  7. 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.

  8. 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.

  9. Ep11 - Managing Fear of Change in Quality Organizations

    Mike Kowolenko and Juan Torres discuss how to manage the fear of change in quality organizations including why change should occur, pressures against change, and how to overcome these pressures. If you have questions, comments, or topics you would like for us to address in the area of…

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  10. Ep10 - Management Review is Good Business

    In this episode, Mike Kowolenko and Juan Torres dig deeper into the process of management review from the perspective that it's an opportunity to improve the organization and it's good business. This leads to ensuring the managers have the proper tools to process all the organization's data to...

  11. Ep9 - Product Release with AI and Machine Learning

    Mike Kowolenko (CEO of NoviSystems) and Juan Torres (NoviSystems Chief Quality Advisor) explore the use of AI and Machine Learning in the product batch release process.

  12. Ep8 - The Product is the Process

    Mike Kowolenko and Juan Torres discuss the relevance of the concept "The Product is the Process" in BioPharma quality given today's advanced analytics tools.

  13. Ep7 - Quality, Innovation, and Culture

    In this episode, Mike Kowolenko, CEO of NoviSystems, is joined by Dr Juan Torres, a multi-decade quality leader who was recently the Chief Quality Officer of a top 5 biopharma company. Mike and Juan discuss the current state of quality in biopharma, the positive outcomes that can be realized for...

  14. Ep6 - Machine Learning

    Machine Learning is an exciting AI tool that has great potential for biopharma manufacturing if deployed properly. In this episode, Dr Mike Kowolenko discusses how to effectively deploy Machine Learning in biopharma manufacturing.

  15. Ep5 - Management Review

    Does your organization simply assess the effectiveness of how well processes are followed? Learn how assessing the content of the processes leads to a more effective organization.

  16. Ep4 - Corrective and Preventive Actions

    Avoid designing Corrective and Preventive Actions (CAPAs) that simply require more human intervention and training. Instead, consider the root cause of manufacturing deviations.

  17. Ep3 - Data Driven Decision Making for Drug Product Release

    Explore the complexities of releasing a batch of drug product and how to apply data driven decision making to enhance operations.

  18. Ep2 - Proving Compliance and State of Control

    Explore how to use your data - numeric, categorical, and text - to demonstrate compliance and state of control.

  19. Ep1 - Quality vs Manufacturing

    Explore the relationship between quality and manufacturing teams in a biopharma manufacturing organization and learn how analytics can be used to improve the organizations goals.

About this show

Explore how to enhance BioPharma manufacturing quality with Fusion Analytics.

Hosted by

NoviSystems

Categories

Technology

Frequently asked questions

How many episodes does The BioPharma Quality Systems Podcast have?

The BioPharma Quality Systems Podcast has 19 episodes on PodParley. The most recent episode was published on December 6, 2022.

What is The BioPharma Quality Systems Podcast about?

Explore how to enhance BioPharma manufacturing quality with Fusion Analytics.

How often does The BioPharma Quality Systems Podcast release new episodes?

The BioPharma Quality Systems Podcast publishes every two weeks, based on its 19 episodes since February 2022.

Who hosts The BioPharma Quality Systems Podcast?

The BioPharma Quality Systems Podcast is created and hosted by NoviSystems.
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