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

Avsnitt(64)

Episode 8: The Specificities of GCP Quality Systems with Nathalie Bourgouin

Episode 8: The Specificities of GCP Quality Systems with Nathalie Bourgouin

Welcome to the eighth episode of Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends! She's join...

1 Okt 201822min

Episode 7: The Philosophy of Quality with Dr. Richard Prince

Episode 7: The Philosophy of Quality with Dr. Richard Prince

Welcome to the seventh episode of Automating Quality. Mandy Gervasio is your host, and she's on a mission to bring you hot industry topics with her fellow life sciences partners and friends, and to pr...

17 Sep 20181h 3min

Episode 6: Data Integrity with Rich Greer

Episode 6: Data Integrity with Rich Greer

Welcome to the sixth episode of Automating Quality. Today's topic is data integrity — a current, hot-topic in the regulated space. Mandy is your host, and she's on a mission to bring you hot industry ...

3 Sep 201824min

Episode 5: The Do's and Dont's of Change Management with Rachel Fountain

Episode 5: The Do's and Dont's of Change Management with Rachel Fountain

Welcome to the fifth episode of Automating Quality. Today's topic is change management — picking up the conversation from their first episode on the topic. Mandy is joined by her co-host, Philippe Gau...

20 Aug 201817min

Episode 4: Measuring Operational Effectiveness with Alan Greathouse

Episode 4: Measuring Operational Effectiveness with Alan Greathouse

Welcome to the fourth episode of Automating Quality. Today's topic is operational effectiveness. Mandy is joined by her co-host, Philippe Gaudreau, CEO of Solabs; and their guest this week, Alan Great...

6 Aug 201820min

Episode 3: Phase Appropriate Quality with Mary Senica

Episode 3: Phase Appropriate Quality with Mary Senica

Welcome to the third episode of Automating Quality. Today's topic is phase appropriate quality — a topic that is especially relevant for anyone in the life sciences industry. Mandy is joined by her co...

23 Juli 201833min

Episode 2: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Episode 2: Optimizing Compliance When Implementing an Automated Training Solution with Jay Turner

Welcome to the second episode of Automating Quality. In this episode, Mandy is joined by Jay Turner of EduJay LLC. Jay's a self-proclaimed learning and development ninja at his latest entrepreneurial ...

8 Juli 201839min

Episode 1: Change Management with Rachel Fountain

Episode 1: Change Management with Rachel Fountain

Welcome to the first episode of Automating Quality. Today's show is focused on change management — a vital topic for the Life Sciences and regulated industry. Your host is Mandy Gervasio, Sales Engine...

25 Juni 201826min

Populärt inom Business & ekonomi

badfluence
framgangspodden
varvet
rss-jossan-nina
rss-borsens-finest
svd-tech-brief
uppgang-och-fall
rss-svart-marknad
avanzapodden
dynastin
borsmorgon
rss-dagen-med-di
rss-kort-lang-analyspodden-fran-di
24fragor
fill-or-kill
ekonomiekot-extra
lastbilspodden
rss-den-nya-ekonomin
tabberaset
rss-veckans-trade