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The Quality Assurance Podcast | PRN Pharmaceutical Research Network, LLC

PRN Pharmaceutical Research Network, LLC
Quality Assurance
Sops (standard Operating Procedures)
Vendor Oversight
ALCOA
CAPA
PRN Pharmaceutical Research Network
Clinical Research
Clinical Operations
Ophthalmic Clinical Research
ICH E6R3
FDA
Ophthalmology
Electronic Trial Master File
Audits
Vendor Qualification
Monitoring Visits
PRN Pharmaceutical Research Network, LLC
Documentation

Welcome to The Quality Assurance Podcast, where we bridge the gap between compliance and efficiency with Smart, Simple, and Sustainable Solutions.

This special series is brought to you by PRN Pharmaceutical Research Network, LLC—your partner in ophthalmic clinical research, with quality and compliance expertise built in.

Joining your host, Chris Milawski, are Jeanette Stewart, the CEO and Co-F... more

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Artwork for The Quality Assurance Podcast

Latest Episodes

“Moving to an electronic system is not going to fix a process problem.” – Ashley Hehr

In this PRN Quality Assurance Podcast episode, host Chris Milawski joins Jeanette Stewart and QA expert Ashley Hehr to break down the reality of moving your opera... more

“Monitors are the eyes and ears of the sponsor.” – Ashley Hehr

In this PRN Quality Assurance Podcast episode, host Chris Milawski joins Jeanette Stewart and QA expert Ashley Hehr to discuss clinical research monitoring and how QA supports and guides... more

Regulators know people make mistakes. And if they walk in the door and they see uber clean source, they will start digging because they know that there's no way anybody could have this good of source." – Chris Milawski  

When mistakes happen in clin... more

"Probably one of the biggest things you run into is the plain simple fact that some sponsors have a set it and forget it attitude about their vendors.” – Chris Milawski 

Many sponsors fall into the "set it and forget it" trap—assuming that because t... more

"If you want a cake to turn out the same every time, you need to follow a recipe. An SOP is a recipe." – Jeanette Stewart. 

But how do you ensure your procedures provide tangible evidence of compliance without causing a disaster waiting to happen?  more

"Knowledge is power. When you know something, you understand something and you can communicate it back to somebody else, that is very powerful." – Ashley. 

But how do you ensure your team actually retains that knowledge without just checking a box?  more

"Quality is everybody's responsibility" – Ashley Hehr.

But how will you implement it without "busting the budget"?

Welcome to the first episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski... more

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Host

Chris Milawski
Host of quality assurance discussions; PRN Pharmaceutical Research Network LLC

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Frequently Asked Questions About The Quality Assurance Podcast

What is The Quality Assurance Podcast about and what kind of topics does it cover?

This show concentrates on quality assurance and regulatory compliance within ophthalmic clinical research, pairing practical guidance with real-world workflow strategies. Across episodes, the discussions highlight ALCOA data integrity, CAPA processes, vendor oversight, SOP design, training effectiveness, and inspection readiness. The format tends to blend actionable tips (templates, checklists, QMS improvements) with candid industry anecdotes about audits, FDA expectations, and the evolving landscape of outsourcing in clinical trials—especially for ophthalmology. A notable strength is the emphasis on making quality an organizational habit rather than a compliance checkbox, with frequent references to collaboration among sponsors, sites, and... more

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The Quality Assurance Podcast launched a month ago and published 7 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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