Episode 60: Investigative Methods with Michael Tyo

Episode 60: Investigative Methods with Michael Tyo

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

Episoder(63)

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quali...

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Episode 54: Risk Management Tools and Techniques with Michael Tyo

Episode 54: Risk Management Tools and Techniques with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a di...

6 Feb 202415min

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters c...

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Episode 52: Supplier Quality Management w. Mandy Gervasio

Episode 52: Supplier Quality Management w. Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by  Philippe Gaudreau, CEO at SOLABS, and Mand...

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Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy ...

17 Okt 202320min

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very specia...

1 Aug 202316min

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! ...

4 Jul 202316min

Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode!   ...

2 Mai 202314min

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