Episode 5 - FROM FINDINGS TO FIXES: Facing Errors Without Fears | The QA Podcast | PRN

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 regulatory standpoint, "uber-clean" source documentation with zero errors is a massive red flag. Agencies expect human error—what they actually look for is the documented proof of how you handled and corrected those mistakes. How do you transition from a culture of finger-pointing to a robust, compliant CAPA system that regulators love to see? Welcome to the fifth episode of The Quality Assurance Podcast: Smart, Simple, and Sustainable Solutions. Join our Host Chris Milawski, PRN’s CEO and Co-Founder Jeanette Stewart, and QA expert Ashley Hehr as they dive into Episode 5, Mistakes Happen: How to Appropriately Document and Follow Up. Brought to you by PRN Pharmaceutical Research Network. A clinical CRO focusing on ophthalmology. [FREE RESOURCE] Unsure if your systems are truly inspection-ready? Gauge your compliance in under 2 minutes with our FREE QA Stress Test Score Card. Download here: https://prnorb.com/slide-deck-download/ Timestamps: 00:00 - 02:06 Introduction to the QA Podcast and Experts 02:06 - 02:46 The Reality of Mistakes in Clinical Research 02:46 - 09:20 Demystifying the ALCOA-C+ Plus Framework 09:20 - 11:54 Proper Documentation vs. The Sticky Note Trap 11:54 - 12:39 Mid Break 12:39 - 18:00 Compliant Corrections: How to Amend Physical Records 18:00 - 19:30 The Core Pillars of a Robust CAPA System 19:30 - 20:20 The Most Frequently Missed Step: Effectiveness Checks 20:20 - 23:56 Closing Other episodes here:    • The Quality Assurance Podcast   or on other major podcast streaming platforms. [CONNECT WITH US] To learn more about PRN, our services, and for any questions you might have: Visit PRN: www.prnorb.com Follow Us on LinkedIn:   / prn-pharm.  . ----- Creative Commons — Attribution 3.0 Unported — CC BY 3.0 Music promoted by Copyright Free Music - Background Music For Videos 👉 @podcastbackgroundmusic