Episode 61: Value Added Quality with Ed Siurek
Automating Quality5 Kesä 2025

Episode 61: Value Added Quality with Ed Siurek

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management.

In today's episode, Ed and Philippe explore how quality can bring added value to a company and discuss strategies to shift organizational mindsets to unlock the full potential of quality departments.

Ed Siurek brings over 30 years of hands-on experience in applying quality standards and ensuring regulatory compliance in the pharmaceutical and medical device industries. He has trained hundreds of quality professionals and is a strong advocate for positioning quality as a driver of business value. After 13 years with a consulting firm, Ed recently transitioned full-time to his own company, ES3 Solutions Inc.

Key Takeaways

00:53 – Introducing Ed Siurek
02:20 – Why is quality sometimes perceived as a cost?
05:50 – Always remember: our products are ultimately used on people
09:02 – "If it's not written down, it didn't happen"
10:20 – Use your risk report — don't let it collect dust
13:20 – How are regulatory bodies viewed in the industry today?
21:15 – What is the role of a quality plan?

Contact us at solabs-podcast@solabs.com for questions or suggestions.
Contact Ed Siurek at Always improving ES3 Solutions

Jaksot(63)

Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia

Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia

Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! ...

4 Huhti 202319min

Episode 46 - Defining Data Quality with Steve Gens

Episode 46 - Defining Data Quality with Steve Gens

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! Today's episode features Steve...

10 Tammi 202317min

Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens

Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens

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! Today's episode features Steve...

13 Joulu 202222min

Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin

Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin

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! Today's episode features guest...

1 Marras 202215min

Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin

Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin

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! Today's episode features guest...

4 Loka 202220min

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 disc...

6 Syys 202225min

Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

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! Today's episode features guest...

2 Elo 202218min

Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin

Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin

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! Today's episode features a conve...

12 Heinä 202222min

Suosittua kategoriassa Liike-elämä ja talous

sijotuskasti
psykopodiaa-podcast
mimmit-sijoittaa
rss-rahapodi
rss-draivi
rss-lahtijat
oppimisen-psykologia
rss-rahamania
rss-porssipuhetta
rss-seuraava-potilas
taloudellinen-mielenrauha
rss-inderes
rss-h-asselmoilanen
rss-bisnesta-bebeja
rss-paatos-podcast-suomen-kovimmat-paatoksentekijat-2
rss-paasipodi
rss-viisas-raha-podi
rss-sami-miettinen-neuvottelija
kasvun-kipuja
rss-bisnespaiva