Episode 61: Value Added Quality with Ed Siurek

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

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Episode 26: Current Hot Trends in the Medical Device Industry

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

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

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

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