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