The Quality Assurance Podcast | PRN Pharmaceutical Research Network, LLC

“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 operations to electronic systems. While technology offers incredible efficiency, a system will not automatically create quality—your workflows do. They dive...

“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 monitors as the sponsor’s “eyes and ears” at study sites. They focus on common pitfalls in monitoring reports (trip reports) and emphasize the content...

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 clinical research, the temptation to sweep them under the rug or use temporary shortcuts like sticky notes can be incredibly high. But from a reg...

"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 they’ve hired a top-tier vendor, they can step back entirely. But from a regulatory standpoint, the buck stops with the sponsor. How do y...

"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?  Welcome to the third episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, PRN’S...

"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?    Welcome to the second episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris, Jeanette St...

"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, Jeanette Stewart (CEO of PRN), and QA Specialist Ashley Hare as they introduce a new series called THE QUALITY ASSURANCE...