Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott

Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott

Welcome to 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! In today's episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021.

Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm's first Quality-focused benchmark. She's had 2 decades of experience as a scientist and researcher.

Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021.

Key Takeaways

01:32 Introducing today's guest: Katherine Yang-Iott, an Analyst at Gens & Associates

03:07 Katherine introduces Gens & Associates and the context of this study

06:07 What were the key findings of this survey?

08:50 What is a QMS in the perspective of Katherine

11:12 What was the goal of the study in terms of information produced?

14:20 How the pandemic has increased companies' focus on supplier management

20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today

21:20 Philippe shares his thoughts on the benchmark's key learnings

22:57 What are the next steps for G&A in the world of quality?

25:15 Mandy thanks our guest and invites listeners to share their feedback

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Episode 24: All About the Quality Risk Management Lifecycle

Episode 24: All About the Quality Risk Management Lifecycle

Welcome to the 24th 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! Today's ep...

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Episode 23: Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner

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Welcome to the 23rd 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! Today, Man...

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Episode 22: Justin Lacombe on Quality by Design

Episode 22: Justin Lacombe on Quality by Design

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Episode 21: Michael de la Torre on GMP Inspection Analytics

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21 Touko 201926min

Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

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7 Touko 201933min

Episode 19: Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

Episode 19: Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting

Welcome to the 19th 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! This week, M...

23 Huhti 201924min

Episode 18: Quality Culture with Lisa Helmonds from MWA Consulting

Episode 18: Quality Culture with Lisa Helmonds from MWA Consulting

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26 Maalis 201921min

Episode 17: Quality Agreements with Lisa Helmonds from MWA Consulting

Episode 17: Quality Agreements with Lisa Helmonds from MWA Consulting

Welcome to the 17th 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! This will ...

12 Maalis 201927min

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