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Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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Episode 60: Investigative Methods with Michael Tyo
Manage episode 448645966 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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 [email protected], Tyo Biotechnology Consulting
Contact solabs at [email protected]
60 episodes
Share
Manage episode 448645966 series 2364916
Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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 [email protected], Tyo Biotechnology Consulting
Contact solabs at [email protected]
60 episodes
All episodes
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Similar to Automating Quality
Some Goodness is hosted by Richard Ellis, a seasoned sales leader passionate about inviting top business minds to share their wisdom. Each episode is only 15-20 minutes, perfect for your commute or workout.
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continue reading
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The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
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Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
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continue reading
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