Automating Quality

Author: SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
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Language: en

Genres: Business, Careers, Life Sciences, Science

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Episode 60: Investigative Methods with Michael Tyo
Episode 60
Tuesday, 5 November, 2024

Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when things go wrong 03:36 The Fishbone method 06:28 Why human error cannot be a root cause? 07:55 The 5 Whys method 09:35 What needs to be included in the investigation report? 11:30 What does the FDA expect from investigations? 12:38 Lessons from recent FDA’s warning letters Contact Michael at mtyo@tyobio.com, Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com