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 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

Welcome to the 39th 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! In today's...

7 Heinä 202021min

Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin

Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin

Welcome to the 38th 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 epi...

9 Kesä 202036min

Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3

Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3

Welcome to the 37th 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! In today's...

31 Maalis 202017min

Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2

Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2

Welcome to the 36th 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! On today's...

17 Maalis 202025min

Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1

Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1

Welcome to the 35th 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 sh...

3 Maalis 202020min

Episode 34: Artificial Intelligence from a Life Sciences' Perspective

Episode 34: Artificial Intelligence from a Life Sciences' Perspective

Welcome to the 34th 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! In this we...

18 Helmi 202023min

Episode 33: Case Study for Implementing an EQMS from a System Owner's Lens

Episode 33: Case Study for Implementing an EQMS from a System Owner's Lens

Welcome to the 33rd 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, Mandy...

4 Helmi 202037min

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020

Welcome to the 32nd 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...

21 Tammi 202026min

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