Mike Kowolenko, Juan Torres, and John Ward discuss how FDA investigations can benefit all parties in the industry if they are backed by science.
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20:45
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20:45
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.
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22:57
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22:57
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.
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24:50
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24:50
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.
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23:36
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23:36
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.
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